Good afternoon. Thanks for joining us for another session at the 43rd JPMorgan Healthcare Conference. I'm Brian Cheng. I'm one of the senior biotech analysts here at the firm. I'm joined by my associate, Marianne Waggie, who is also in the audience. On stage, we have the CEO from Kyverna Therapeutics. And I will now pass the mic to Warner Biddle for a short presentation, followed by a live audience Q&A. Warner, the stage is yours.
Thanks, Brian, for the introduction, and thanks for hosting us. My name is Warner Biddle. I'm the CEO of Kyverna. And I'm really excited to be here to share with you our strategic plan and strategic priorities for 2025, and how we're going to continue to build on our established leadership in this space as we pioneer the way forward for CAR-T and autoimmune diseases. This is our standard safe harbor statements with some forward-looking statements. I won't spend a lot of time here, but you have these. I do want to spend some time on this, though. This is our mission at Kyverna. And we're all about the power of CAR-T. And I can tell you firsthand from my previous company that I've seen the power of CAR-T firsthand in the hematological spaces. And this is why I was really excited to join this company four months ago.
We're not playing for small changes here. We're playing with changes that change and transform patient lives. And we're disrupting medicine in the process with paradigm shifts that we're making every day across these diseases. These are diseases that are refractory for patients. They're often on chronic therapies, often not being treated very, very well. They have poor prognosis, poor quality of life, and they have a high impact on the cost of the system. Our mission at Kyverna is about liberating these patients from autoimmune diseases through the curative potential of cell therapy. Now, I joined the company about four months ago. And over the last four months, I've been working with my leadership team, really focusing us around a few key priorities.
This is going to be a pivotal year for us as we turn Kyverna from an early-stage, early research company to a later-stage development and eventually paving a way for a pathway to commercialization. We've got three key areas that we're focusing in on. These are the three pillars here. First, we want to deliver the first autoimmune CAR-T in the neuroinflammation space. We're 40% enrolled with our first indication with SPS, with our pivotal Phase II trial. We're targeting a BLA in 2026. We have two fast-follower indications with MG, or myasthenia gravis, as well as LN, lupus nephritis. We have Phase I LN data reading out later this year. We have Phase II MG data, our interim Phase II MG data, expected in the second half of this year as well.
In addition, we want to expand and build on the power of KYV101 and expand further with KYV102, which is our next-generation proprietary whole-blood rapid manufacturing process, and we're working on the non-clinical package and expect to file that IND in the second half of this year as well. All of this is underpinned by a cash runway that takes us into 2027, and we believe we have the resources and the people that we can actually take to deliver on these key inflection points and these key deliverables. The other thing that gives me confidence and gives us confidence that we're able to deliver and execute on this plan is that we have built an established leadership position in this marketplace. We've treated the most patients in this market with over 50 patients across 50 different indications. We have a unique CAR-T construct.
We're the only CAR-T company in the autoimmune space with a fully humanized CD19, CD28 co-stimulatory domain with the potential for differentiated safety and differentiated efficacy. We've built up a really strong track record in terms of manufacturing excellence with over 95% manufacturing success rate. And we've actually been investing in new innovations that are going to improve that even further. We have a strong dialogue with regulatory authorities. We have now nine regulatory designations with two RMATs, four Orphan drugs, and three fast-track designations. And this puts us in a position to take our development programs and move them forward quickly. In addition, I've been working hard over the last four months to really build a world-class team surrounding myself with leaders in this space that understand late-stage development as well as CAR-T and autoimmune diseases.
We've put together a very thoughtful and strategic approach that we believe prioritizes our existing portfolio and unlocks the potential that we have. Stiff-Person Syndrome is the first tip of the spear. We're calling it the tip of the spear because this really unlocks the rest of our portfolio. And this really allows us to rapidly establish a footprint in the autoimmune space and allows us to do this in a very focused manner. We can then pivot from there and actually build on that with two larger fast-follower indications, first with Myasthenia Gravis and then also with Lupus Nephritis. Lupus Nephritis will be our first indication in the rheumatology space.
Leveraging all of our ongoing clinical data, as well as the large data set of patients we've already accumulated, as well as our ongoing IITs, we believe this can unlock and accelerate future growth potential and future unlocked potential indications. Starting with Stiff-Person Syndrome, I'll go into a little more detail here. This is an excellent first indication for us. There are significant unmet needs for these patients. These patients deteriorate rapidly. There are no approved therapies, and there's a high cost burden for these patients on the system. By focusing in on Stiff-Person Syndrome, we are allowed to focus our organization in a way that we can execute with speed. We're enrolling our first trial now. And as I mentioned a few minutes ago, we're 40% enrolled. It will allow us to finish this by mid-2025 this year with results in 2026.
Initially, we're focusing on IVIg failures because this is the area with the highest unmet need. But because there's no established treatment in this space, we believe there's a potential for KYV101 to expand further into broader populations here. We have the potential with SPS to be the first CAR-T company to launch in this indication. But this gives us also the opportunity to be the first CAR-T company to launch in the autoimmune space, period. When you look at the data, this is the data that gives us confidence with SPS as an initial indication. This is data that we presented last year at ECTRIMS. You can see reduction in key antibody titers, namely anti-GAD65 and others as well.
But if I can draw your attention to the middle panel, this is showing improvements in mobility score or the timed 25-foot walk test, which is a validated clinical endpoint in other neurological conditions. And it fully encapsulates the impact of SPS on these patients and the value of CAR-T in terms of treating these patients. Because we're seeing significant impacts in this key clinical endpoint, while also eliminating the need for background immunosuppressants, we believe we have an unprecedented efficacy and an unprecedented construct here that can set a new standard of care for this disease. Myasthenia Gravis, or MG, is an excellent fast-follower. It allows us to build on and amplify our presence in neuroinflammation diseases. And it is also very, very synergistic with SPS, but targeting a patient population that's 10x larger than Stiff-Person Syndrome.
We recognize that there's a lot of new therapies being studied in this area, but we believe many of them are suboptimal. They require chronic treatment, and they all require a significant cost to the system as well. We're actively enrolling right now in our Phase II study. And we expect to have an interim readout on this study in the second half of this year. And with an RMAT designation, we believe we can move very, very quickly. Overall, we're seeing transformative results with these patients. And we believe there's an opportunity to move into earlier lines of therapy as well. These are the data that we presented last year at ECTRIMS in our first three patients dosed at our target dose with KYV101. And again, we're seeing significant reductions in key antibody titers.
Again, drawing your attention to the middle panel, this is a focus on the clinical impact of KYV101. And you can see significant improvements in muscle function here. In particular, MG-ADL score. An average in our patients was six when patients entered our study. And to see this decline to zero after just 90 days of therapy without the need for background immunosuppressants anymore. Again, this is an unprecedented result that we're not seeing anywhere. And we really believe this is why we have an RMAT designation and why we believe we're differentiated versus other standards of care in this space. Lupus nephritis is still a key indication for Kyverna. And with a strong presence in neuroinflammation, we're able to scale into lupus nephritis, which will be our first indication in rheumatology.
We believe we have a faster pathway here because we're focusing on lupus nephritis, not the broader SLE patient population overall. And these are some of the patients with the highest risk for end-stage renal disease, kidney failure, and death. And it's a tremendous burden on these patients, both from a symptoms perspective, but also a tremendous burden on the healthcare system itself. We're on track with our enrollment for our Phase I study. And we'll be seeing the interim or the top-level results for our Phase I study in the second half of this year. We also believe that we're seeing transformative impact with these patients and believe there's opportunities for KYV101 in earlier lines of therapy with lupus nephritis. Overall, we believe the lupus nephritis market is at least as big as the MG market.
Again, these are the data that we presented last year, this time at the ACR conference, seeing significant reduction in key antibody titers here, double-stranded DNA, as well as normalization of complement. But again, I want to draw your attention to the middle panel, which is the clinical efficacy panel. The key with lupus nephritis patients is stabilization of kidney function. And you can see here that we're stabilizing eGFR while significantly reducing proteinuria, all while reducing and all while eliminating immunosuppressants and reducing or eliminating the need for glucocorticosteroids. I think it's important to note as well that these initial four patients that we treated with lupus nephritis had some of the highest disease severity scores, high chronicity scores in these patients. So to see these kinds of results while eliminating the need for background therapies is truly unprecedented and would not be possible over two years ago.
In fact, we had an ACR symposium. And the key opinion leaders, Dr. Schett, which Brian and I were talking about earlier, as well as Dr. Caricchio, were debating and discussing this. And they were reminding the audience that we have not seen these kinds of results in these severe patients before. And it's something that we need to continue to move forward for the betterment of our patients. I think the reason that all of us are so excited about CAR-T therapy is the real promise for long-term durability and long-term remissions and being able to do that with a single treatment. And what's really exciting for us at Kyverna is that we're now seeing our first patients that are dosed at the target dose for KYV101 having durable and long-lasting remissions beyond one year for all three of our patients in our first priority indications.
Again, this is without the need for retreatment. It's without the need for background immunosuppressants and without the need for glucocorticosteroids. In fact, the middle panel highlights Denise, our first treated MG patient. She's now out to over 19 months, and this is the longest recorded impact from a CAR-T therapy in the MG space and truly setting a high bar for the precedent that we're moving forward with. Diving into her case just a little bit further, she has a really incredible journey, if you will. She's a 33-year-old mother of four. She's been living with this disease for 12 years, and the last few years in particular have been particularly troublesome as she's been in and out of ICU 5x . She's been on mechanical ventilation. She's had tracheostomies. She's been on feeding tubes just to stay alive.
All of this has just been an incredible burden on her, obviously. She was refractory to multiple sets of treatment. Nothing really worked for her. But in May of 2023, she was our first patient to be dosed with KYV101. And as we talked about a few minutes ago, she responded quickly and rapidly to therapy. And now, 19 months out, she's been disease-free. This is again without the need for retreatment and without the need for background immunosuppressants. She's able to walk. She's able to play with her kids. She's able to see a life that she never would have even thought would be possible. And I think this is really underlying the true story of the potential and why we're so excited to come to work every day and work on KYV101 is because we can transform patients' lives like Denise. But we're not stopping with KYV101.
I want to talk a little bit about KYV102 and how we want to reach more patients like Denise with a proprietary next-generation whole blood rapid manufacturing construct. KYV102 adds a lot of significant advantages for patients. Because it's a whole blood construct and a whole blood process, we don't have to do apheresis, which means you eliminate an important step for patients and make it easier in terms of their patient journey. The faster turnaround means we can get it back to patients faster. It also lowers our overall cost of goods. Overall, we believe there's a significant impact on the system. It actually unlocks capacity and makes the treatment journey for patients that much easier.
Because we're actually building off the backbone of the KYV101 and using the fully humanized and validated construct here with KYV101, we're able to move into the non-clinical stages and finish this and file our IND fairly quickly with KYV102. In fact, we're going to be intending and targeting to file our IND in the second half of this year. For patients, again, we're simplifying their journey. For the system, we're reducing and simplifying and reducing the amount of resources that are needed in the system. But more importantly, we believe this is unlocking a whole new potential for CAR-T therapies that will allow us to go beyond our initial three indications that we're targeting now and allow us to focus in on even bigger and broader indication patient populations. This is a summary of our 2025 pipeline and our priorities.
And you can see we're hyper-focused on a few key priorities that will deliver catalysts for patient impact and company value. At the same time, we're going to take a data-driven approach. We're going to use our largest patient data set that we've accumulated so far, as well as the ongoing clinical data and the IIT studies. And we'll use this data-driven approach to unlock the next indications that we'll be targeting as a company. Underpinning all of our success and our belief in these priorities is our belief in KYV101. We have the only CAR-T in the autoimmune space with a fully humanized CD19, CD28 co-stimulatory domain construct. We believe that it's been designed for potency and the ability to actually differentiate and get deep B-cell depletion and give patients a chance at an autoimmune reset.
We believe this is why we're seeing the potency and why we're seeing the clinical outcomes and the transformative efficacy in the clinic. In addition, it's been designed for safety because it's fully humanized. And we're not seeing any high-grade CRS or high-grade ICANS now in the over 50 patients that we've treated to date. We believe actually now that we're transforming and seeing these clinical outcomes for patients in a one-and-done therapy. And I want to point out that although we're studying these patients under the full guise of a clinical trial program, we believe at one point, given the profile we're seeing, KYV101 has the potential to be an outpatient-administered construct. Ultimately, I think we recognize that the autoimmune space is getting very crowded. But we believe that KYV101 is doing something fundamentally different from the other standards of care in this space.
Current standards of care may be disease-modifying. They may be aiming to slow the progression of the disease down or maybe even potentially stop the progression of the disease, but KYV101 is different. We're calling this more of a disease-clearing approach. We're actually getting at the root of where the disease is residing with deep B-cell depletion, getting at targeted tissues and setting a new immune reset for these patients. Again, this is why we believe we're seeing transformative outcomes in the clinic and why we're seeing the potential for cure in these patients. All of this in a single administration, all of this while eliminating the need for background and chronic therapies. Again, we're transforming patients' lives in fundamentally different ways. Here is the summary of our near-term milestones, and you can see that we're focused in on execution.
We're focused in on clinical data and generating clinical data in the short term. We'll be reporting our top-line pivotal results for SPS in the first half of 2026. But in 2025, the key priority for us is to finish our SPS Phase II trial, which we believe is pivotal. In myasthenia gravis, we're looking at confirmatory regulatory pathways and interim results in the second half of this year. And with lupus nephritis, we'll also be reporting our top-line Phase I results in the second half of this year as well. As I mentioned a few minutes ago, we believe we have the right development path right now with our non-clinical work to file an application for an IND for KYV102, our next-generation construct in the second half of this year. Again, all of this is underscored by our cash runway and the team that I'm forming around me.
So we believe we can execute and deliver on these key milestones. In summary, I hope you can see that I'm very, very excited about the progress we're making and excited about the transformative year ahead. We have plans to be the first autoimmune CAR-T therapy in the autoimmune space with SPS. We have fast-follower indications with MG and lupus nephritis. And we have plans for the next generation of CAR-T therapy with KYV102. I'm really excited to be here. I'm really proud to be working with this team that I see a lot of them here in the front row with me. And I believe we're in a position of strength. And I believe by focusing on a few key priorities, we're going to be able to deliver and expand our leadership as we continue to pioneer the power of CAR-T in the autoimmune disease space.
With that, I'll pause and thank you. I think we're going to take a few questions.
Great. Let's begin the Q&A session. Warner, if you can join me here on the stage. I guess for those of you who are in the audience, if you have any questions, you can raise your hand and we have a runner on the floor. For those of you who are joining virtually, you can also submit questions on the conference portal. I think over the last year and a half that I've been following this story, I think one of the key questions that I keep hearing is more about just the understanding around how easy it is for cell therapy to be applied in autoimmune diseases more from a regulatory standpoint. I mean, I think there's also that component of how does it fit commercially, right?
But just without talking about the specific target indications, I guess, Warner, can you just kind of give us a sense of just how has the hurdle from a regulatory perspective evolved over time for cell therapy products to potentially tackle these autoimmune diseases that you're thinking of?
Yeah. Well, I think it's a bigger question. I think it's even broader than regulatory. I mean, the short answer is, Brian, I think we've learned a lot over the last 18 months to two years. Even in terms of our clinical development, we're understanding now how to actually set up the clinical trials in a more rapid manner and actually start to enroll patients in a more rapid manner as well.
One data point that I've been sharing with some of the analysts and investors today is that when we were getting our IND with lupus nephritis, which was our first indication, the time from IND to our first enrolled patient was just under 18 months. Now with SPS, the time from our IND to our first enrolled patient was under four. So we're actually learning a lot about how to set up these CAR-T centers. We're learning how to connect the CAR-T experts, which have been largely in the transplant and hematology space, and connect them with the neurologists and the rheumatologists and nephrologists so that we can accelerate and enroll patients in the trials. We're also learning about where these patients are in the network so we can actually refer them in quicker so that we can actually enroll them in the clinical studies as well.
Pivoting and just answering your question about the regulatory environment, I believe we're in a significant advantage here with Kyverna with the two RMAT designations. We're able to have really positive dialogues with the FDA about the pathway forward. And given the fact that we've seen these huge transformative effects and huge effect sizes with our KYV101, we believe we can design these clinical studies in different ways. We don't need the large n size that maybe some other traditional therapies might have. And in the dialogues we're having with the FDA, we're very, very confident that we can move these forward in a way that's going to have an impact for patients and have an impact for the company in a rapid manner.
So maybe just shifting to now your lead indication for SPS, just how should we think about the market opportunity here for SPS? And how do you define the bar for success in your ongoing pivotal study since you're really the one that's kind of trailblazing the field to go into SPS? So has the FDA kind of given you some guidance on what to look for? And do you have a sense of which measure will be important to make sure you have commercial success in the near future?
Yeah. Well, we're measuring a lot of outcomes in our clinical study. But the primary one is this 25-foot walk test, which has been validated, as I mentioned a few minutes ago, across a number of different neurological indications. And we have confirmation in the conversations we have with the FDA that this is a validated endpoint in SPS as well because it encapsulates all the key factors that patients are actually enduring when they're going through this disease.
And we're seeing the significant results that I presented a few minutes ago. So we have very strong confidence with the primary endpoint that we set in place. We're also, of course, measuring secondary endpoints like the Hauser index and stiffness index and these other things that are well established in the SPS field. So we feel very confident about the clinical endpoints that we're putting into place. And then turning to the market opportunity, again, this is a very focused indication. And some of these initial patients that we're targeting are refractory to IVIg. And those are obvious ones that we're going to be able to target in the short run. But there are no approved therapies here. So even IVIg doesn't attack and get at the root cause of this disease and really change the course of this disease around.
So we believe KYV101 will have a broader implication beyond these initial data sets or patient sets as well.
I guess, how do you think about just expanding beyond? I think you have this chart that talks about the potential beyond just the IVIg failure patients within SPS. So what will you want to see before you start to expand beyond just IVIg failure? And I guess, can you just talk about just what's your plan to expand into perhaps milder patients within SPS?
Yeah. Well, I think, I mean, the important thing to keep in mind is not only are there no approved therapies in this space, the patient prognosis. It just gets progressively worse over time. Patients don't get better. And you're seeing from our initial patients that patients are not only stabilizing, they're getting better. So the effect size that we're seeing with SPS is extremely large.
So although we're initially targeting IVIg failures, as you noted, we believe the potential is well beyond that. And I think the clinical impact is not difficult to see. It's very apparent. Patients that have been bedbound or in wheelchairs are having a transformative effect on their lives and can now walk and have a significant impact in their quality of life. So we believe this is going to allow us to expand and use and leverage the clinical data. While educating the community, of course, and educating our patients around the benefit of CAR-T therapies, we believe we'll be able to expand the early lines of therapy for sure.
I think as it ties to rare diseases, there's always a question of how you think about pricing. What's your early thoughts? I know that it's still relatively early. But how should we think about, especially for IVIg failure, which I assume that they used a lot of IVIg over the years and they're still not responding? So how should we think about a proper pricing range for the application of KYV101? Is there a benchmark that we should start to think of when it comes to modeling the potential sales trajectory for 101?
Yeah. I think it's too early to comment specifically on the price. But I think this is another reason why stiff person syndrome is a very excellent first indication because there's such a huge unmet need. The cost burden on the patients is significant as well. And we believe there's a really high-value argument for CAR-T therapy in this space.
Again, without commenting specifically on a price, we're very, very confident that the market access and ability to demonstrate value in this space is going to be very, very high.
Great. And we have a question from the floor.
Thanks for the update. That was very interesting. Is it good?
Yeah. I can hear you.
Yeah. Perfect. Then that's what matters. I have two questions, actually. The first one has to do with manufacturing. I think if there's anything that all CAR-Ts have in common is that demand outpaced the supply after launch. Could you share with us? I mean, there are many moving parts with CAR-Ts. For one, there are personalized therapies. There are plasmids. There are viral vectors. There's the cells themselves. Could you share with us what is Kyverna's manufacturing strategy to assure a successful commercialization when you get there? Thanks.
Yeah. Yeah. Well, and I pointed that out at the beginning. I think this is one of the strengths that we built up. And now we've treated the largest data set of autoimmune patients with KYV101, which means we've had to have the manufacturing build it up. And we've had over 95% manufacturing success rate right now. And we announced last year that we've actually expanded into a second manufacturing site beyond WuXi now and to Elevate, which gives us confidence that we're going to have the manufacturing platform and the ability to deliver successfully for patients, not just in our clinical trials, but that we'll be able to scale that up over time. In addition, we're investing in next-generation manufacturing automation and next-generation manufacturing processes. They're going to help improve that and speed that up and also reduce our cost of goods.
But we'll inform you about that more later as we continue to progress on that. But we feel really confident that we can deliver for our clinical trials as well as scale up and build ourselves into position for launches.
Do you see that happening in-house like at Kite or rather staying with outsourcing?
Right now, we're using external supply. And that's the plan.
Yeah. Just to wrap it up real quick, can you share about your allogeneic pipeline?
We still have 201 in our pipeline. And we still believe in the long-term potential of allogeneic therapy in this space. But right now, with the cash runway we have, we really want to focus on a few key priorities. And you can see we're really excited about the transformative data that we're seeing in SPS, MG, and LN with KYV101.
So that's a clear focus for us in the short term because we believe that will bring value to patients and bring value to the organization. At the same time, KYV102, I mean, it's a whole blood rapid manufacturing. And you think about it from the context of an allogeneic therapy, the real goals there is about how do you simplify things for patients as well as reduce cost of goods. And I think we're able to do that with KYV102. We're able to simplify the process by eliminating apheresis. We're able to speed the turnaround time and reduce cost of goods in the system. So in effect, we believe KYV102 actually is like an allogeneic in terms of the simplification while still having the efficacy and proven safety with KYV101.
We have another question from the audience.
Hi. Hi. Thanks very much. It's very interesting. I'm curious, based on the structure or the vector that you're using, what is your expectation or even better yet, observation in the patients you treated as far as the antibody depletion, specificity, or breadth, and whether or not there is any compromise in other realms of antibody-based immunity?
I can tell you at a high level, we're seeing a consistent B cell depletion and a rapid B cell depletion with patients. Peak expansion of the CAR-T is within seven to 10 days. We're seeing a normalization, like I said, of complement and other antibody titers that we're reducing antibody titers, as we talked about earlier. This is having a clinical impact overall. Maybe I'll get Sham, though, as our Chief Product Officer, maybe just to chip in a little bit about the specificity of long-term impact on the patients.
I'm just wondering about other antibodies that may not really be desirable as targets to reduce.
I see what you're saying. Yeah, yeah.
I think one of the key things that we're very excited about is the combination of CD19 with CD28. So we have this wide depletion, but we don't lose humoral immunity. And so we've got these people that are now not immunocompromised, that are able to protect themselves against the daily viruses and infections that they might have been exposed to previously, but at the same time, really focusing down on the pathogenic drivers of the disease that we're tackling.
Are you able to observe that?
Yes.
Thank you.
Any questions from the audience? I guess just going back to the safety profile so far with KYV101, how confident are you with the safety today? I think there is overemphasis of whether any of the cell therapy program is going to hit Grade 3. Grade 3 is sort of the benchmark for ICANS, CRS. So how confident are you that you will continue to see the safety profile that you're seeing today? And is it just the matter of increasing the denominator you can potentially see one, just how confident you are with the cells today?
Yeah. Well, I think as we talked about a few minutes ago, we've got the largest data set that's been studied in the autoimmune space now, over 50 patients, 15 indications. We're not seeing any high-grade CRS, no high-grade ICANS. The cases that we are seeing are very manageable with supportive care and usual care that's now been well validated in the CAR-T space. So we feel very, very confident about the safety profile that we have.
As I mentioned a few minutes ago as well, we believe that the safety profile we have here is going to allow KYV101 to be used in an outpatient setting as well. And I think that's going to be really important as autoimmune CAR-T usage continues to increase. And we see increased usage on the hematology side as well. Increasing and utilizing the available capacity in the system is actually going to be really, really important. So I believe we're making the right steps there. And we feel really, really confident with what we're seeing.
Can you discuss your thoughts around the competitive dynamics? I think over the year, we are seeing bispecifics trying to create a space specifically in some of the autoimmune that you're looking at, like lupus and MG. So, I mean, SPS, you have your own niche opportunity, right? But as we think about the second and the third and so on, how do you think about yourself fitting against those that are off different modalities?
Yeah. Well, I think it comes back to this fundamental difference of what CAR-T therapies like KYV101 are doing. We're talking about this deep B cell depletion, being able to get at the B cell depletion in targeted tissues and have this opportunity for an immune reset. This is something that non-CAR-T therapies may try to do but aren't effectively doing right now, and still have to prove that they're able to make that happen, so this is why we believe we're seeing the transformative clinical impacts.
You want to talk about MG, the reduction in our scores with MG-ADL scores from six to zero and being able to do that in 90 days with one-time treatment without the need for background immunosuppressants. There's a lot of other things and companies that are interested in the MG space. But no one's demonstrating that transformative effect and being able to do it with a one-time therapy. So again, we've got to continue to execute on our clinical trials, continue to generate the data that will put us on a pathway to commercialization and registration and commercialization. But we feel really confident with the construct we have and its ability to really deliver this transformative effect. And when you think about it and you talk to the patients that are actually impacted by these diseases, this is what they ultimately want.
They don't want to be reminded every month or every quarter that they have these diseases and they're still burdened by the therapies that they're taking and they're not quite delivering the efficacy that they want when they're still burdened by side effects. They ultimately want what Denise had in the case study we talked about a few minutes ago. And I think that's extremely powerful. And we're going to continue to not only generate the clinical data that will support that, but I think a big part of what Kyverna is doing as a leadership position here is telling that story more broadly to motivate not only the physicians but the patients that are out there and everyone else that's interested because we're doing something completely different that hasn't been done before.
So maybe just on 102, I think it's interesting that I think today you talk a little more about 102. And I think it's interesting to understand just how we should think about 102 kind of fitting into a big picture. And is 102 kind of the ultimate goal for you to flip over 101 development to 102? And just how should we think about 102 fitting into the entire portfolio?
Yeah. I mean, I won't go through it again. But I think KYV102 offers all these transformative benefits for patients, simplifying the patient journey, less impact on the healthcare system as well, faster turnaround time, lower cost of goods. So all these coming together, I think, are going to have huge benefits.
And like I was alluding to, I think there's potential here not just to support the initial indications that we're talking about right now, but I think this is really going to help unlock larger patient populations and some of the other indications that we started studying in our pipeline and portfolio. So although we need to put the pieces of this together, first things first, we've got to file the IND. And you'll hear more about that in the second half of this year. But I think this is going to allow us to unlock huge opportunities with larger patient populations because it's going to be easier for patients to use and bring it closer to patients where patients are actually out of the system.
Just to kind of wrap up, I guess, how oh, there's one question from the audience.
Question. Given the durability, how do you see potential re-dosing, maybe, let's say, two years down the line? Is it possible? Does 102 help? Is it something you consider?
It's something we're considering and talking about, but it's not something we're looking at yet. But it's something we're going to look at in ongoing clinical development programs. Are we done?
I have one more. But how do you think about partnerships? I mean, do you see the need to partner off?
How was the trial closed, Brian? I love that. I love that.
Just to test the audience, just to make sure you guys are awake. How do you think about partnerships? I mean, I think lupus--
Yeah, just to answer that one really, really quickly. I mean, as we stated, we have the cash runway and feel very, very confident on delivering the priorities that we put forward in our plan. We're well on our way to executing this. And so I feel really, really good about that. But of course, we'd be interested in looking at partnerships that could help us accelerate this or maybe unlock potential in other indications that we're not prioritizing right now. So I mean, that's part of the reason why we're here at JP Morgan is to potentially explore some of these things as well.
Okay. Well, thanks for your time today.