Good afternoon and welcome to the Jefferies 2025 Global Healthcare Conference. My name is Ashwin Serafiani with the Jefferies Investment Banking team, and it's my great pleasure to introduce Warner Biddle, CEO of Kyverna Therapeutics. Kyverna is focused on liberating patients through the curative potential of cell therapy. Its lead CAR-T cell therapy candidate, KYV-101, is advancing through late-stage clinical development with registrational trials for stiff-person syndrome and myasthenia gravis, and two ongoing multicenter phase I and II trials for patients with lupus nephritis. Thank you. Thank you. That was a great summary. My name is Warner Biddle. I'm the CEO of Kyverna. On behalf of the Kyverna team, I'm really pleased to provide you an update on how we're progressing and paving the way to be the first CAR-T autoimmune company in this space. Back in JPMorgan, back just a few months ago, we laid out a very clear and thoughtful strategy on how we're going to advance our programs with Kyverna and specifically KYV-101 into the clinic and on a pathway to a BLA and eventual commercialization. I'm really pleased to say that we've been progressing on all of our goals that we laid out earlier this year, starting with the fact we've got a very unique construct with KYV-101 itself that's been specifically designed for both efficacy and safety advantages versus competitors in this space. In addition, we're moving forward with our lead programs, first stiff-person syndrome or SPS, where we've now fully enrolled our pivotal phase two trial and looking to actually advance and move the results of this trial in the first half of 2026, as well as advancing our guidance in terms of the filing of the BLA into the first half of 2026 as well. In addition, for myasthenia gravis, we've now enrolled our initial six patients into our phase two trial with myasthenia gravis, with those results reading out in the second half of this year. More importantly, we've reached agreement with the FDA on a pivotal design for our pivotal registrational phase three trial, which we'll share some of those results a little bit later this year. In addition, we're continuing to advance our programs with lupus nephritis, as well as KYV-101, which is an important second-generation advance for our programs in this space. Overall, we continue to trailblaze in the autoimmune therapy field, and I'm really, really pleased to say that we're utilizing our cash runway that takes us well into 2027 so we can fully capitalize and achieve all of these key milestones. Underpinning our success and actually underpinning our belief in our portfolio and the success that we've had to date is the design of KYV-101 that's been uniquely designed and optimized for autoimmune diseases. We're the only CAR-T in the autoimmune field that has a CD28 co-stimulatory domain, which we believe provides deep B-cell depletion and an opportunity to provide an immune reset, and a good reason why we're actually seeing the strong clinical results and strong durable results in these early patients that we've actually treated. In addition, because it's a fully human design, we're actually designed for safety as well, and we've now seen no high-grade CRS, no high-grade ICANS in the over 70 patients that we've treated to date. Overall, we believe this construct puts us in a really, really strong position to provide a unique construct in this marketplace, but one that can also be administered in an outpatient setting, which we know will be critical as we get to market from an autoimmune space. In addition, we're actually seeing some really strong translational medicine to support the differentiation of CAR-T therapies in KYV-101, specifically some of the ability for deep B-cell depletion of CAR-T therapies in dissected lymph nodes. The data you see on the left here was presented back at ACR back in the fall, which shows how CAR-T cell therapy can actually have a more complete and deep B-cell depletion of therapies versus standard rituximab or anti-CD20s. In addition, on the right, we're starting to see these results bear out with KYV-101 specifically, and in this case, in bone marrow resections, we're actually seeing, again, deep B-cell depletions, but also a repopulation of naive B-cells that are unpathogenic and actually are indicative of the fact that we're actually having an immune reset in these patients. This is actually leading to a really fundamental difference in terms of our construct, in terms of the safety profile that we're seeing. This is a summary of the compassionate use patients now that we've treated in over 40 patients. This program is now closed, but we've now been accumulating all of this data across 40 different patients. Across all of these patients, we're seeing across 15 different indications, no high-grade CRS, no high-grade ICANS. The CRS that we are seeing are mild, very, very predictable and manageable within the normal constructs and usage of CAR-T AE therapies that are really, really standard in the therapies now and in the clinics that are treating these patients. All of this is summarized in terms of the strategy that we laid out earlier this year, which is really a focus on neuroinflammation diseases starting with stiff-person syndrome and myasthenia gravis. As I'll talk about in a few minutes, there's a huge synergy between these indications and it really allows us to move quickly to establish a market leader position in two key areas with huge unmet needs and where we can differentiate ourselves both as a company, both in terms of the construct itself, followed by lupus nephritis, which is an important indication for us as a company as we continue to advance forward, but really providing an opportunity to unlock future opportunities with the ongoing IATs and clinical studies that are happening in this space to look at future potential of how we can use KYV-101 and our follow-on constructs to treat more autoimmune patients that desperately need these therapies. This is a summary of our pipeline, and you can see that we're highly focused right now, first on stiff-person syndrome with the ongoing pivotal phase two trial that's now fully enrolled. As I mentioned earlier, that will read out those results in the second half or the first half of 2026, as well as we moved up our guidance in terms of the BLA filing into the first half of next year as well. In terms of myasthenia gravis, we're finishing enrolling in our phase two. The FDA has actually given us a go-ahead to actually shorten that phase two trial now and pivot towards a pivotal registrational phase three design, which will release those details on that design a little bit later this summer. For lupus nephritis, we're finishing enrolling in our KYV-101, KYV-103 studies with results coming in the second half of this year as well. In addition, we're thinking forward about how we can continue to advance our programs and move into a next-generation product with KYV-102, which is our whole blood proprietary rapid manufacturing construct. This is going to allow many, many advantages both from a patient perspective as well as a manufacturing perspective. We're setting guidance to actually file the IND in the second half of this year as well. In addition, we'll be looking thoughtfully at some of the other IITs and ongoing clinical studies that we're doing in order to fully evaluate what the next opportunities are for us as a company. We know there's huge opportunities beyond these first three indications and this next-generation construct. Ultimately, we're playing for something really transformational and huge for these patients. These are the first two patients that we've treated with KYV-101 in both stiff-person syndrome and myasthenia gravis. In both of these cases, we're seeing lasting and transformational impacts in terms of the durability that these patients have been experiencing. Our first patient on SPS is now beyond 19 months. Denise, our first MG patient, in fact, she was our first patient that was treated with KYV-101 overall, she's now at 24 months out post her treatment. In both of these cases, these patients are free of their active disease. They're off background immunosuppressants. They're off background glucocorticosteroids and living transformed lives that we think is actually really, really important in differentiating in this autoimmune market. These two indications are also really important for us because they really set us up to start and establish a neuroinflammation franchise with a number of different synergies that we can see across these two indications, including using the same academic centers, the same neuromuscular departments and neuromuscular physicians. It is the same treatment centers, the same commercial and med affairs infrastructure that we will go to market with, as well as we can continue to leverage the same CMC approach. In fact, we have confirmation from the FDA that our filings with the CMC will both support the SPS indication as well as the MG indication and future indications as well, which really puts us in a powerful position as a young company moving forward. Diving into a little bit more deeper details for stiff-person syndrome, this is a really important and I think very interesting and really strategic first indication for us as a young company. This is an important disease that has no effective treatments to date. It is an autoimmune disease. It's B-cell mediated, really instigated by antibodies for the anti-GAD65 antibodies as glycine receptor and others as well. These patients actually have GABA receptor difficulties and abnormalities in their system that actually causes their muscles to tense up over time. It progressively gets worse over time, first starting with these initial spasms, but eventually patients have truncal and lower limb involvement where they actually lose the ability to walk, lose the ability to walk effectively. Many of them end up in wheelchairs and actually many of them end up bedbound over time as well, which is a completely horrible prognosis. There are no available therapies right now that actually have an impact on their patients from a clinical perspective. They are treated with a number of different things, including symptomatic treatments and muscle relaxants and pain relievers. They are also using a number of off-label immunosuppressants. IVIG, for example, is used in a majority of these patients. For all of these patients, their disease continues to progress over time, getting progressively worse, which really makes the results that we are seeing from KYV-101, at least in these initial patients that we have treated from a compassionate use perspective, really, really remarkable. We are actually seeing here not just reductions in the key antibody titers, but actually improvement in mobility. This is the time 25-foot walk test that you see in the middle panel, where you're seeing patients in the high teens and low 20s in terms of the number of seconds it takes for them to actually walk 25 feet. A normal person, by the way, would walk this in four or five seconds. These patients are taking significantly longer. You're seeing after one treatment with KYV-101, a significant reduction in this time 25-foot walk test, which is the primary endpoint in our pivotal clinical trial. In addition to this clinical response, we're seeing these patients come off background immunosuppressants as well as reducing or eliminating glucocorticosteroids, which again is having a transformational impact in terms of the quality of life these patients are receiving and in terms of what they're seeing in terms of managing their daily lives and their families. This is an outline of the pivotal clinical trial, the KYV-101 study that we're now fully enrolled with the 25 patients, as it says here. The primary endpoint is the time 25-foot walk test, which we will measure at 16 weeks. There's a number of secondary endpoints as well as measuring the antibody titers and, of course, the safety profile. As I said, we're well on track with this study. We've now fully enrolled it in under seven months, and we'll be reading out these results in the first half of next year and moving to file our BLA in the first half of next year as well. We also believe there's a tremendous market opportunity, particularly given that we're going to be first mover advantages in this space. There's a number of patients, in fact, between 2,000 and 2,500 patients in this prevalent patient pool that is already refractory to existing patients and already well known within our existing centers. We believe that we can readily address that with the initial launch of KYV-101. In fact, now looking at the data and the fact that this has not been a disease that has been well characterized in the past, we believe that this total addressable market is actually somewhat understated. We believe the market is actually closer to probably 2,000 or 6,000 patients over time, particularly as we see the rate of anti-GAD65 testing actually increasing and the level of education that is going into the marketplace right now continues to increase and we continue to identify and surface more patients. Taking a look at Myasthenia gravis, again, this is a space that I think is getting more well defined, particularly as more competitors come into this space. Even as we look at the number of new advances in this marketplace, there's still a huge unmet need as these patients face debilitating and ongoing progressive muscle weakness that impacts their breathing, impacts their ability to swallow and eat, and eventually impacts patients so they end up hospitalized in many cases on intubation or in and out of ICU with these so-called myasthenia crises. What we're seeing from these therapies that are now getting approved, there's a mild or moderate impact in terms of their ability to reduce the MG ADL scores, but nothing that really significantly changes the course of their disease or treats the underlying course of their disease the way we have an opportunity to do with KYV-101. In addition, if we take a look at the data that we're now seeing from our initial patients that have been treated through the compassionate use program, we're seeing in this middle panel this significant reduction in MG ADL scores. Traditional therapies or therapies that are now being approved in this space are seeing deltas or reductions in MG ADL scores of between two, two and a half, three, three and a half sometimes. No one is seeing a reduction in MG ADL scores of six or seven down to zero and holding these patients at zero for a durable period of time. In addition, when you think about it, this is patients we're treating with a one-time therapy, being able to eliminate background immunosuppressants as we've seen with these first initial three patients. This becomes really a transformative impact that despite a lot of competitive pressures in this space, we believe we're going to be carving out a unique opportunity for KYV-101 to be highly differentiated. This was the design of the ongoing phase two study for KYV-101 in MG, the so-called KYZO-6 study. The FDA initially asked us to do 20 patients in this study. It has now allowed us to reduce this down to six patients. We'll be reading these results out in the second half of this year. Because of the initial results that we're seeing in the compassionate use program, as well as the initial results that the FDA saw in these initial patients, they're allowing us now to pivot straight to a registrational phase three design, which we're going to share the details of that design a little bit later this summer. Really, really exciting opportunity for us to get that confirmation from the FDA that allows us to move quickly. I think it reflects not only the power of KYV-101, but the huge unmet need that's still surfacing in this space. Again, there's a huge market opportunity here, roughly 10 times larger than SPS. Even with the available therapies in this marketplace, there is a market addressable for second line plus patients beyond the 30,000-40,000 patient range that we believe will be readily addressable for KYV-101 once launched. In addition, I really want to hone in here on the differentiation of KYV-101 versus the other competitors in this space. Again, we believe we're doing something fundamentally different here with a therapy that's able to give this deep B-cell depletion, give patients a chance at an autoimmune reset, and really see these durable results that we're seeing in our first initial patients. Like I've been saying, these other therapies provide some moderate impact in terms of MG ADL reduction, but no one's seeing consistently these large MG ADL reduction scores bringing patients down to an MG ADL score of zero and holding them there over a consistent durable period of time. We really believe that doing this with a one-time therapy, as well as doing it from a really positive safety and tolerability profile, gives us a huge advantage, allows us to differentiate in this important marketplace. In terms of additional opportunities, we're still focused on lupus nephritis. As I said earlier, we're looking to finish enrollment of our phase I study, the KYV-101, KYV-102 studies, and read out those results in the second half of this year. As we presented last year, we're seeing some transformational results in terms of stabilization of eGFR, reduction in complement or normalization in complement, rather, reduction in key antibody titers, elimination of background immunosuppressants, and reduction or elimination of glucocorticosteroids. Really a basket of clinical benefits for these really high disease chronicity and high disease activity score patients that we're seeing now with lupus nephritis that really have a huge unmet need. We still feel there's a role here for KYV-101, and we'll be looking at the results from our phase I study and then looking internally at how do we design the next phase of the clinical development program. In addition, as I mentioned earlier, we're not stopping with KYV-101. We're looking ahead to KYV-102, which is our next generation whole blood rapid manufacturing construct. This is a proprietary construct that's going to allow us to eliminate the apheresis step for patients, which will simplify the patient journey and allow them to take this initial step towards CAR- T therapy closer to their homes and where they live. In addition, because it's a rapid manufacturing process, we're going to see a reduced turnaround time for these patients, but more importantly, a significantly reduced cost of goods. This is a really, really important program that's going to allow us to unlock the potential that a lot of allogeneic therapies were hoping to do for these patients, but do that with the power of an autologous therapy and working off the backbone of KYV-101, which we know is now proven across the multitude of these different patients and these different indications. We are working behind the scenes right now on moving this program forward with the preclinical and the translational medicine and the CMC package data. This is going to be ready for filing in the second half of this year, and we'll be putting our IND into the FDA. Overall, I want to summarize, and I hope you're feeling the momentum that we're seeing as a young organization, but we're really moving forward in terms of our plans and rapidly moving forward to bring Kyverna forward as a leader in this autoimmune space. Starting with this neuroinflammation franchise concept with stiff-person syndrome and myasthenia gravis, advancing both of these programs now fully enrolled with SPS, looking to file the BLA in the first half of next year. The MG program now getting confirmation from the FDA on our pivotal design, so we'll be able to rapidly follow with the second and larger indication. Looking to the future in terms of broadening the pipeline, both in terms of lupus nephritis, KYV-102, and looking more thoughtfully at the next indications and how we can continue to progress the programs as a company for bigger and larger indications in the autoimmune space. Overall, I want to reiterate that we have the cash runway in hand that takes us into 2027, so we're able to deliver on these important milestones. I'm just really excited on behalf of the entire team of the progress that we're making for the company, but more importantly, the progress that we're making for patients that desperately need these new therapies. Thank you.