All right. Good afternoon, everyone, and thanks for joining us at the Morgan Stanley Global Healthcare Conference. I'm Michael Goltz, one of the biotech analysts here, and it's my pleasure to introduce Warner Biddle, CEO of Kyverna Therapeutics. Before we get started, I just need to read a quick disclaimer for important disclosures. Please see the Morgan Stanley Research Disclosure website at www.morganstanley.com/researchdisclosures. If you have any questions, please reach out to your Morgan Stanley sales representative. With that, Warner, I'll turn it over to you. Maybe make some introductory comments. You've recently given us a bunch of updates, which I'd like to sort of hit on all those. For people who aren't familiar with the story, if you can just give them a quick sort of background.
Thanks, Mike. Thanks, everybody, for hosting this and for inviting us. Yeah, a lot of exciting updates. We just held an investor relations day a couple of weeks ago that really gave an overview of the progress that we're making here as an organization. For those of you that are not close to what Kyverna Therapeutics is doing, we are a CAR-T specialized company specializing in autologous CAR-T cell therapies and next-generation therapies for the treatment of autoimmune diseases. What we were sharing a couple of weeks ago is just the tremendous progress that we're making over this past year since I've joined the organization, really focusing in on advancing our early clinical data into late-stage clinical with the eventual goal to actually put this on a path to BLA and registration and, of course, commercialization.
Starting with stiff-person syndrome and myasthenia gravis, two really important indications in the neuromuscular space and the autoimmune space that are largely underserved. SPS doesn't have an approved therapy, myasthenia gravis, although there's a lot of new therapies in this space. You're still not addressing the underlying cause of this disease. I think what we're really excited about is the early data that we're generating with KYV-101, which is our first construct, and how transformative it is for these patients. We're actually moving now in both of these indications into a registration of clinical trials for both, which we're excited to continue to advance as an organization.
Great. Maybe you can just start by talking a little bit about why CAR-T cell therapy has been such a promising approach for autoimmunity.
I think it comes down to the fundamentals of what CAR-T therapy is doing versus other therapies that are being used in the autoimmune space. We know many of these diseases are B-cell mediated. CAR-T therapy, and in particular CD19 CAR therapy, which is what KYV-101 is, addresses and has this potential to give this deep B-cell depletion in these patients. In fact, our construct is very unique. We are CD19. There are others out there that are CD19, but we're the only one with a CD28 co-stimulatory domain fully humanized design, which gives us, we believe, an opportunity to give this deep B-cell depletion while also having a really effective safety profile as well that's manageable and tolerable in the clinical setting.
We believe this is what CAR-T therapies are actually doing, is addressing this underlying course of this disease and, in effect, giving not just a B-cell depletion, but actually normalizing T-cell function, having a chance to reduce cytokine production as well, these things that contribute to the long-term inflammation that these patients are facing, and in effect, have this immune reset, which then is what we believe is driving these long-term durable remissions that we're seeing in our first patients.
Yeah. The data is very promising. You also recently reached a milestone of treating 100 patients already with KYV-101. Maybe just talk about sort of the emerging profile, maybe on the activity side and safety side so far.
Sure. Yeah, 100 patients. It was an excellent milestone for us to celebrate internally as an organization as well. I think that puts us in at the lead or one of the leading companies in terms of the number of patients that are treated in the autoimmune space, which we're really excited about. Not just from the perspective of understanding how this therapy works in terms of treating the efficacy, it's really giving us a broad perspective in terms of the safety of KYV-101. The patients that we've treated thus far, we're not seeing high-grade CRS, no high-grade ICANNs. This is reinforcing this across a broad group of patients across multiple different indications that we've really got something here that can be effective clinically, but also something that can be used from a commercial perspective when we get it out into the clinics at some point.
Maybe just talk about broadly where you think this therapy can fit in in different diseases. Is it more of late-line therapy after you've tried other treatments and then you maybe get 101, or is it something that you can also maybe use in earlier lines of therapy as well?
That's a great question. I think we're still in early days here. The patients that we've initially treated with KYV-101 tend to be patients that have been refractory to at least something. If you take the case of stiff-person syndrome (SPS), which is our first indication that we're going to be seeking approval for, there are no approved therapies for this disease. As you and I have talked about before, the natural history of this disease is horrible. Patients get progressively worse in terms of their symptoms, and it's effectively impacting the vagabenergic neuromuscular junction for these patients. Patients get these initial spasms and muscle tensions that eventually progress over time and impact their truncal and lower limbs. They have trouble walking. A lot of times, they need walkers, or some of them end up being in wheelchairs or bedbound.
The natural history of this disease just progressively gets worse over time. There's no approved therapies, but a lot of them get a variety of immunosuppressants, muscle relaxants, pain relievers, IVIG, but nothing works in terms of reversing that course of that disease. Our pivotal phase 2 trial is ongoing now, and we've publicly announced that we're going to be reading out that data in the first half of next year, filing the BLA next year. It looks like we could be the first actual approved therapy in this space for a patient population that desperately needs something. In terms of answering your question, a lot of these patients will have been on some of these other therapies before.
Because they're so ineffective, we believe that KYV-101 could be used relatively early in their diagnosis because of the fact that there's no approved therapies and that patients will just get progressively worse over time.
Yep. You mentioned sort of stiff-person, sort of first-to-market strategy. Sort of mind us what's next, and then what's sort of next beyond that as well and how that all fits together.
Yeah. When I came here, we were looking at the different autoimmune indications where we could move with KYV-101 as sort of a first-mover advantage. Stiff-person syndrome was chosen on purpose because of the size of the patient population. It is a relatively narrow patient population. Because of that and because of the fact there's no approved therapies and the progressive nature of the disease, it allowed us to design a really efficient clinical strategy. We have a single-arm, 25-patient study that is registrational. It's allowing us to move very, very quickly. In fact, we fully enrolled that trial. Like I said, we're going to plan to read that out in the first half of next year.
That really sets us up for our foundation to be not just the first to launch an autologous CAR-T in stiff-person syndrome, but we could be the first company, or we're planning to be the first company to launch an autologous CAR-T in autoimmune period. That actually allows us to create a foothold, if you will, for the next indication, which is myasthenia gravis. There's a lot of synergies between these indications because they're both neuromuscular autoimmune diseases that are many times treated in the same departments within these academic institutions. There's a lot of synergies both in terms of the clinical development planning, but also from a manufacturing and eventual commercialization there.
By focusing in on these two indications, it'll allow us to move first, create this first-mover advantage, if you will, in the marketplace, and then use that as a platform for the next components of our longer-term strategy, which we're looking at in terms of next-generation construct KYV-102, but also newer indications like the emerging data that we're seeing with KYV-101 in MS and RA and others. Lots of things to come.
Yeah, keep launching new indications over a long period of time.
Keep building the organization. That's what we're working towards.
Sounds good. Maybe just SPS, right, your first-to-market strategy, maybe talk a little bit about the market opportunity there. Obviously, you mentioned devastating disease, no treatments for these patients. What, how big could this market be?
It is probably more significant than we initially thought. There's been some emerging research both on the epidemiological side. The University of Colorado has published this. There's others that are coming, as well as our own analysis of the marketplace and claims data, etc., that's triangulating the size of this marketplace. We believe the epidemiology or the prevalence of this disease in the U.S. alone is 6,000 patients, which for a company of our size actually provides a really significant opportunity for a first-mover CAR-T to be launched into this space. Of those 6,000 patients, we know that there's 2,000 to 2,500 of these patients that are already refractory on multiple courses of IVIG, monthly or biweekly IVIG, and progressively getting worse.
There's a huge value argument in the system, not just the chronic nature of the disease and the chronic nature that these patients have to be managed, but the cost to the system is also huge, which I think provides us a really strong value argument when it comes to payers and when it comes to the commercialization of this. We've been thinking through that a lot. The stiff-person syndrome is a great initial indication for all those reasons, allowing us to move quickly, first-mover advantage, but also from this commercial opportunity.
Can you just talk about how those patients are specifically identified, and then roughly how many of those 6,000 are actually currently sort of identified?
There are 6,000 that are clinically diagnosed now.
Some are on various sort of stages of their disease and progression of their disease. The way they're diagnosed, it's a combination between a clinical diagnosis. There's a number of stiffness indices, the Hauser Ambulation Index, the stiffness index that patients are used in terms of the clinical diagnosis. It's also confirmed with an antibody test, the GAD65 test, GAD67, GlycinR. Patients need to have both of these in order to have a confirmatory diagnosis for SPS. That's the other thing that's changed, if I can maybe add that in. Over the past few years, testing for this disease hasn't been universally accepted or available. The GAD65 testing now is becoming more available, which is actually contributing to this increased recognition and understanding of what the real prevalence of this disease is.
LabCorp, for example, is now carrying GAD65 testing, which wasn't common in the past, which is making it easier for these patients to get that confirmatory diagnosis.
Maybe you can just talk about what you've seen with some of the patients you've treated and what's the key endpoint here and what's the impact.
Yeah. This is the exciting part, right? You've seen this. We've talked about it. These patients are getting progressively worse over time in terms of their ability and their mobility. The primary endpoint that we were measuring in these initial patients that we treated through a compassionate use program, and it's the same primary endpoint that we're using in our pivotal study, is the time 25-foot walk test, which is a functional test that literally measures the time it takes someone to walk 25 feet. That's a standard test that's used in a number of other neuromuscular conditions, including MS, that often uses a secondary endpoint there. Because it's functional and a continuous variable, it's something that's very sensitive to the nature of where the patients are at.
As I said, the natural history of these patients is this time 25-foot walk test starts out poor and just gets progressively worse over time. The average patient that has stiff-person syndrome will walk a 25-foot walk test in about high teens, maybe below 20s in terms of 20 seconds to walk this, whereas you and I and people in this room would walk it in, you know, five, six seconds. There's a huge delta between where these patients are at when they're enrolled in our clinical studies to where they could be from a normal perspective. In these initial patients that we treated with KYV-101, we saw this significant reduction of 50%, 60%, bringing these patients down to seven, eight seconds on average from a time 25-foot walk to this, which is a significant reduction.
Many of these patients that have had trouble even getting out of bed or out of their wheelchairs are now walking with walkers, or some of them are now walking without walkers, which is an incredible turnaround in terms of their quality of life.
Yeah. You talked a little bit earlier about your phase 3 trial design. It's the KYSA clinical trial study, you know, 25 patients, single arm, and that same time 25-foot walk test as a primary endpoint. You were also able to get FDA alignment on the study design. Maybe just talk a little bit about that process, your interactions with the FDA, and was there anything specific that they were focused on?
The benefit with this is we've secured an RMAT designation and an orphan drug designation. This has really allowed us really frequent conversations with the FDA. In fact, we have, you know, between SPS and MG, which we also have an RMAT designation with, we're having regular interactions with the FDA, which have been very, very positive. I think specifically on the SPS indication, they saw a disease again that has no approved therapy, patients progressing and having significant morbidity and quality of life impact. In fact, they saw the videos of these patients that we've shown in different forms before, and that has also added to their perspective and understanding of the disease. They helped us in terms of thinking about this design and validating the design that we were putting forward. All of that's been relatively positive.
At this point, as you know, it's been heads down just around execution. We're fully enrolled in the study, so we're heads down and preparing for that readout, that data readout, and that we want to share in the first half of next year.
What do you need to show on the primary endpoint to get approval? You mentioned 50 to 60% improvement in that endpoint. What is our minimum threshold or something that you have to show?
Yeah, it's a good point. I mean, from a clinically relevant change in the time 25-foot walk test, it's about a 20% reduction. We're powered to show a 25% reduction or greater in terms of our clinical study. As I was mentioning, what we saw in our first initial patients that were treated through the compassionate use program is a 50% to 60% reduction. It gives you some idea of the powering and how we're thinking about the design of the study. That was the other conversation we had with the FDA. They recognized that we had this huge effect size, and we're doing it with a one-time therapy that also, you know, allows patients to get off their background therapies as well. That's the other thing that's really important here. They're not on background IVIG or taking background immunosuppressants.
They're able to take this one-time KYV-101 and have this clinical impact. All of that led into this design and support from the FDA.
Yeah. Talk about just the durability you've seen with SPS so far. What's the longest patient use you've had?
Our first patient now, and we announced this a couple of weeks ago at the IR event, is now at 23 months and counting. This patient had a significant reduction in their time 25-foot walk test, which is remarkable, again, off background immunosuppressants and background therapies, and had a clinically meaningful impact in terms of their quality of life as well, which is remarkable.
Yeah. I've asked you this question before, but just the ultimate durability. You have good durability so far. How far could it go?
That's what we're working towards, to try to understand how long this can go. We're really in a leadership position here. No one has got patients on, you know, CAR-T therapy longer than we have to show these kinds of results. Just harking back to the conversations that we're having on the IR event from a couple of weeks ago, Dr. Mappetti from Stanford was talking about in the context of MG, rather, but I think this applies to SPS as well. He was remarking that if patients could come off all their other therapies and have a drug holiday and have a significant clinical impact for a year, that would be remarkable. Now the fact that we're approaching two years in SPS, we're past two years in MG and counting, I think, is really pointing to the transformative effect that we're having for these patients.
Maybe one other point to add to that, maybe giving a little bit of perspective, I had worked in CAR-T therapies in my prior role, but on the hematological side of my prior company. What we saw in the maturing data in the LBCL, for example, hematological space is as patients reach that three-year mark, it was highly predictive for a long-term durability of effect out to five years and beyond. Obviously, that's speculative. We need to see how the data continues to mature in the autoimmune space. If we see this durability of effect hitting this two and three-year mark, it's highly probable that this could also be indicative of something that gets patients on the road to a cure at some point, which is what we're aiming for here. It's too early to call it that, but I think this is what we're aiming for as a company.
Makes sense. Since you could be in a position to maybe launch your first drug later next year with data in the first half.
Possibly.
You know, maybe just talk about your commercial strategy and preparations at this point.
Right. We're doing a number of things. First of all, it starts with the whole BLA readiness and systems readiness internally, which for a young company like ourselves doing this for the first time is a big undertaking. In addition to that, we're working on scaling the manufacturing and planning for that, as well as doing pre-commercialization efforts around education and getting ready in the marketplace, working with patient advocacy groups, for example, and preparing for an eventual launch. What we do know, and we've talked about this as well, the strategic choice in going with SPS first is also important from a commercialization effectiveness perspective because the capital outlay that we're going to need in order to prepare for that launch is significantly less than if we picked a different indication. Only because these patients are highly concentrated in a lot of key centers of excellence around the U.S.
We know where they're based. A lot of them actually cycle through and are in touch with these academic centers on a regular basis. We know this because through our clinical trials, we were oversubscribed, and patients were traveling distances in order to receive therapy and treatment. What that means is we're going to be able to launch with a relatively contained commercial footprint and go to market in a relatively cost-effective way while still addressing the majority of the patients that are out there. This will allow us as a first step as a company to start to generate revenue as we prepare for new indications, which will be larger and larger and allow us to expand over time.
Makes sense. Maybe now we just can shift to myasthenia gravis. You know, you've shown some very sort of promising data there as well. Maybe just touch on some of that data and what you're seeing there.
Yeah. The exciting thing there is that although there's been a number of therapies that are being studied and approved, and it's really opening up the options for patients in terms of the treatment choice that they have, at this point, nothing has shown what KYV-101 has shown in our first three patients that were treated with myasthenia gravis. Namely, that we're not just seeing reductions in MGDL scores, which is kind of the ticket into the game, so to speak. You have to achieve those significant reductions. We're doing that to a significant level. Our first patients were at sixes and sevens, and we're bringing them down to zero, which is important from a clinical symptom perspective, having that kind of a delta, which is quite remarkable. Embedded in that is the fact that we're bringing these patients down to MGDL score of zero.
We're looking at MSC, which is zero or one, or MGDL score of zero. This is ultimately what patients want. They want this opportunity to be disease-free, if you will, not have the symptoms of this disease. Being able to do that and hold these patients at an MGDL score of zero, and now our first patient is now out to two years, Denise, and she's now past her 24-month mark, without the need for background immunosuppressants, without the need for background steroid therapies, etc., we're really giving somebody a chance at a transformative impact and clinical impact that goes beyond just reducing MGDL scores, which I think this is what we're working towards and what we'll be measuring in our trial.
If we're successful in generating that data in the pivotal clinical study that mirrors or approaches what we're seeing in these first patients that we treated with the compassionate use patients, we'll have set a new standard. We'll be setting a new gold standard for the treatment of MG.
Yeah, you're planning to share this phase 2 data in the fourth quarter of this year. What data should we expect, and what should we expect in terms of the reduction? I mean, zero fair kind of expectation for all these patients?
The patients we'll have, we'll have six patients in that phase 2 interim result. The patients that have been on therapy the longest will be up to nine months, and some will be less than that. We won't have fully matured data, but there'll be a decent number of patients that'll be at the six-month mark and beyond. We're going to be looking for trends. Exactly. We're going to be looking for trends. Are they seeing significant reductions in MGDL and QMD? Are the MGDLs approaching zero or heading towards zero? Are we also seeing significant reduction in their antibody titers, which, again, is correlated with these results? We're also going to be looking at the safety, of course. Do we get more confirmatory data on the safety of KYV-101 in these patients? That will help round out the package for us.
Yeah. You also mentioned, you know, a phase 3 trial that you're going to start. You also sort of talked about the trial design, which is a bit unique. Maybe just hit on those points in terms of the phase 3 trial design or what's sort of unique about it.
Yeah. We're really excited about this. This is the, you know, the first time that we'll have an autologous CAR-T cell therapy study in the MG space. We're going to be able to do this with 60 patients, which I think a lot of the other therapies in the space are, you know, having to study a lot more. What's also unique about the study is that patients are randomized one-to-one to either KYV-101 or a standard of care, which we're allowing background immunosuppressants and access to complement inhibitors, etc., to mimic what patients would be treated on in a real-life setting. It will allow us to actually compare and claim superiority versus a standard of care, which is ultimately the goal that we're looking at. We're going to be looking at significant reduction again of MGDL and QMG, which are co-primary endpoints.
We'll also be looking at the percentage of patients that are able to achieve MSC or MGDL at zero. This, I think, will actually start to set a new benchmark, like I said, for what therapies can do in the MG space.
Can you talk about the co-primary and why you set it up that way? Is there anything specific there?
MGDL is a patient-reported outcome. It's done in conjunction with physicians, but it's patient-reported. The QMG is a physician outcome scale, so they're complementary. The results are correlated in the impact that they see in patients. We set this up partly in consultation with the FDA. This helps minimize the placebo effect, if you will, that you might see in patients. We're also using an independent assessor in order to assess these results. We're also taking a look at these results over 24 weeks. That's where the primary endpoint is going to be measured at, which also helps minimize the placebo effect of any other compounders earlier in the treatment.
Yeah. Can you also talk about just the standard of care arm, and does it include FCRNs, and just the rationale for that?
Yeah. Patients can be on FCRNs, they can be on complements, they could be on a variety of other background immunosuppressants coming into the trial. The inclusion criteria is advancing disease on two immunosuppressants, which could be biologics or standard immunosuppressants, or one immunosuppressant and have had chronic plasmapheresis or IVIG treatment. There are a lot of options. We're looking to see and bring into this study a variety of different patient types and background therapies that they've been on. Once they're in the study and they're randomized, we're allowing standard of care to be on traditional immunosuppressants plus complement inhibitors if that's what they were being treated on before. Patients won't be allowed on FCRNs because of the waxing and waning efficacy that patients have on that. It's difficult to normalize, and we need a steady efficacy measure for patients coming into the actual readout of the primary endpoint.
Patients could have been on FCRNs coming into the trial. The patients that we're targeting are patients that would have been on FCRNs and have failed those FCRNs. What we've seen from our market research and from talking to physicians as well is, as promising as some of the FCRNs have been, there's still a huge unmet need where a large percentage of these patients have continued advancing disease or refractory disease or need something else.
Yeah. Can you talk about just the patient population too you're enrolling? I think you're including some naive patients as well.
Naive?
Naive to treatment.
No. Patients will have been on either two immunosuppressants or an immunosuppressant plus, you know, chronic plasmapheresis or IVIG. They will have been failed and have had advancing disease. They need an MGADL score of at least 6 and a QMG score of greater than 11. It's a moderate to severe patient population. The international classification for myasthenia gravis as well is from 2A to 6. Those patients will be included within. It's a broad group of patients. It's patients with a high unmet need. I think it's also, given the fact we're allowing patients with different backgrounds of therapies coming into the trial, I think we'll give a really good body of evidence of the effectiveness of KYV-101 and what it can do.
You plan to start the phase 3 by the end of this year. How important is the phase 2 data to starting that study, or is it not important? What's kind of the next steps, the remaining steps to getting that underway?
Yeah. The phase 2 study, as we talked about earlier, we'll be reading out the interim results of that phase 2 study in the fourth quarter of this year. The phase 3 study, though, we're starting and moving forward with pivoting from the phase 2 into the phase 3 now. The phase 3 is not contingent on the phase 2 results. We've already had those discussions with the FDA. Based on the initial results from the compassionate use program, which has been pretty remarkable, as well as the initial patients that were treated in the phase 2 study, the FDA allowed us to actually stop or truncate the phase 2 study early and move into the phase 3 study. We're moving on that now.
Gotcha. Maybe just talk a little bit about the competitive landscape and just where you think you can fit in.
Yeah. Like I said, I think there's a huge unmet need, even with these new therapies in the marketplace right now. Nothing's doing what KYV-101 is showing, both in terms of the clinical impact of these patients and having patients like Denise that are now out past two years without the need for other therapies and being able to do this with a one-time treatment. That's remarkable on its own. I think it comes down to some of these fundamental differences of what we're doing versus FCRNs or complements or other things. We're actually targeting what we believe is the heart of the disease, the pathogenic B cells that are driving the underlying cause of these symptoms. By normalizing this immune environment for patients, providing them this immune reset, we believe we're actually providing something that will be durable for patients over the longer term.
In terms of differentiation, there's going to be a significant number of patients that have, you know, even in these, you know, think about the clinical trial patients we're enrolling that have, you know, failed or been refractory to two different types of immunosuppressants and a variety of those different types. There's a large group of patients out there that really, really need these therapies.
Yep. We got a few minutes left, but I wanted to sort of hit on KYV-102 as well. Maybe just talk a little bit about that program and how it's different from 101.
We're really excited about KYV-102. This is our next-generation construct that uses the same backbone of KYV-101 in terms of the CAR. The CAR construct's the same, but it's on a manufacturing platform that allows us to use whole blood from patients rather than apheresis. That's really important because we believe it'll be easier for patients to actually, you know, collect the whole blood. They won't necessarily have to go to an academic center in order to do that like they traditionally do with apheresis. By doing this closer to home, we believe we can simplify the journey for patients, at least initially, and skip some of the early steps that patients have in terms of accessing CAR-T.
In addition, it's a rapid manufacturing process, which means that we can reduce the turnaround time for patients, which will help, but also it significantly reduces the cost of goods for us, which, again, will help us as we continue to expand into other indications in the future. We talk about, you know, some of the indications that we're exploring beyond SPS and MG. We believe this gives us a lot of flexibility from a manufacturing and eventual commercialization perspective to come into some of these larger indications and make the journey easier and simpler for patients.
Yeah. Maybe we can just talk a little bit quickly, just your current cash position. You have a lot of studies ongoing. You're pushing things forward fairly rapidly here. You know, what's the runway look like and what does it cover?
Yeah, that's important. We've reported out at the end of Q2 that we have $212 million in available cash. We're on track to have that cash runway take us into 2027, as we've indicated before. We're sticking with that guidance, and it supports all of these near-term milestones that we talked about: the readout on SPS and the filing of the BLA, the interim readout of the phase 2 for MG, the enrollment around the MG pivotal phase 3 study, as well as the readout as well of the MS and RA data, which we didn't really talk about, but we have two ongoing IITs in those diseases, which are exciting. That covers that, as well as the initial IND filing for KYV-102.
We're doing a lot, but we're doing it in a very efficient way and working on this to sort of ensure that we're focusing in on these milestones that are going to drive value for the organization.
Great. Maybe in the last minute and a half, I could just ask a quick sort of macro question. This is a question we've been asking all our companies. Just, you know, sort of what's been most impactful for you guys from the regulatory side? Would it be what's going on at the FDA, MFN, or tariffs impacting you at all?
It's probably the FDA. It hasn't really impacted us, but if that's the most, it's the thing that's probably highest on our radar, given where we're at in our journey. The MFN, obviously, it's too early, and we need to plan around that from a commercialization perspective in terms of pricing. We've got time to work through the details there. From a tariffs perspective, we've been asked this in the past. We've got actually a minimal impact from a tariffs perspective. We're manufacturing in the U.S., primarily sourcing in the U.S. These things are actually really important. From an FDA perspective, obviously, with the changes that are happening there, that's obviously on our radar. What we've been really encouraged by is some of the public statements that Dr. Prasad and others have come forward with around this charge, if you will, to the industry to come forward with more impactful medications, transformative medications for patients, one-time therapies, ones that can save the system money and provide value back in the system and not require patients to have chronic therapy. When you hear these things being spoken about and you look at what we're delivering as an organization, I think we align with that mission fairly well. We're excited that we can maybe contribute and maybe help build towards that mission as well.
Great. It looks like we're just about out of time. Why don't we wrap it up there? Thanks so much, Warner. Appreciate your time.
Thanks, Michael. It's a lot of fun. Thank you.