Kiniksa Pharmaceuticals International, plc (KNSA) Earnings Call Transcript & Summary

Welcome everyone to the 39th Annual JPMorgan Healthcare Conference. My name is Anupam Rama. I'm one of the senior biotech analysts here at JPMorgan. I'm joined by Matt Bannon and Tessa Romero from the team. Our next presenting company is Kiniksa. And speaking on behalf of the company, we have CEO, Sanj Patel. Before I turn it over to Sanj, just wanted to highlight for those listeners on the webcast, you can submit a question via the ask the question button in the portal, and I'd be happy to ask the question on your behalf. Sanj, I'll turn it over to you.

Thanks, Anupam. I was just thinking that, and I can't believe it's been over 10 years together, you and I at this conference. It's actually -- time flies when you're having fun. It's actually my 11th time presenting, but it's certainly the first in this format. But regardless, I do want to thank you and JPMorgan for hosting us today. So today, I'll review our corporate slide deck as well as go over our strategy and pipeline and highlight our next phase of growth for Kiniksa. Slide 2 in that deck lets you know that I will be making forward-looking statements today that are subject to risks and uncertainties. A review of these statements and risk factors are found on that slide as well as under the heading of Risk Factors in our SEC filings. Slide 3 is what we're all about. Just over 5 years ago, we set out to build a patient-focused company, to help patients that are suffering from devastating diseases with unmet need. And we are well on our way. As well as having a proven team, we've assembled a sequential pipeline of well-designed drug candidates that modulate the immune system. All 4 of our assets are based on validated mechanisms and have the potential for differentiation as well as multiple follow-on indications. So there's clearly a lot more to come. Since we started, we've executed on our announced time lines and enhanced the value of each of our 4 assets. We also have a strong balance sheet, which we expect to fund our operations into 2023. 2021 marks an important step in our evolution. We're nearing our first potential commercial launch with a PDUFA date for rilonacept in recurrent pericarditis in the first quarter of this year. And we plan to advance our other product candidates with a number of important catalysts expected for mavrilimumab, Vixarelimab and KPL-404. Slide 4 gives you an overview of our pipeline of product candidates. At the top of the slide, you'll see that we're evaluating rilonacept in recurrent pericarditis. Next, we're evaluating mavrilimumab in giant cell arteritis and severe COVID-19 pneumonia and hyper inflammation. And Vixarelimab in prurigo nodularis. And we're also conducting a clinical trial for KPL-404, which is our anti-CD40 program. In terms of the commercial rights for our programs, for rilonacept, if approved in recurrent pericarditis, we have a 50-50 profit split with Regeneron for the approved indications in the U.S., and we maintain worldwide rights for the other 3 product candidates. On Slide #5, you can see that each of our 4 product candidates, and importantly, they have the potential to be best-in-class therapies, and they're all supported by validated mechanisms. As you'll see on that slide, the initial indication for each one of our product candidates offer attractive commercial prospects, as indicated by their current addressable populations. Slide 6 shows you that 2020 was an exceptional year of execution at Kiniksa, marked by encouraging clinical data across all 4 of our product candidates. And that execution set the stage for what we expect to be a transformational 2021. With rilonacept, we had highly statistically significant efficacy data from our Phase III trial. And the FDA accepted our sBLA filing with a priority review late last year. Our PDUFA goal date is this coming March 21. And if approved, we expect a commercial launch in the first half of this year. With Mavri, the primary and secondary endpoints of our Phase II GCA study achieved statistical significance. We also received a U.S. IND for the evaluation of Mavri in COVID-19 pneumonia and hyper inflammation. We expect Phase II data in the first half of this year, and we're really excited with the fact that Mavri has broad potential utility, and we look forward to providing net steps for the rest of its development in the first half of this year. With Vixa, our Phase IIa study in prurigo nodularis, also met its primary endpoint with statistical significance. It also highlighted the potential for its dual mechanism to offer pruritus relief and nodule improvement, and we're now conducting a Phase IIb study across a range of once-monthly dosing regimens. And with KPL-404, we expect final data and safety follow-up from all the dose cohorts in the first half of this year. Starting with Slide 7, I'll go into a bit more detail on each of our product candidates. Given the proximity to a potential launch with rilonacept, I'll also focus on our commercial launch strategy. Rilonacept is a once weekly, IL-1 alpha and IL-1 beta cytokine trap, which is in fact an already approved and marketed biologic in the United States for CAPS and Dara, both of which are genetic auto inflammatory diseases. We've been evaluating rilonacept for the treatment of recurrent pericarditis, which is a debilitating auto inflammatory cardiovascular disease for which there are currently no FDA-approved therapies. And the potential for rilonacept to become the first FDA-approved treatment for recurrent pericarditis will be an important step forward for patients that are suffering from this debilitating and painful disease. Slide 8 highlights the key areas of unmet need in patients with recurrent pericarditis. And our Phase III study generated data in these 4 key areas, and that includes the resolution of acute episodes, the prevention of future episodes, steroid-sparing disease control and quality of life. And we plan to address the unmet need for the treatment and prevention of this disease with a targeted therapy. Moving on to Slide 9. We are laser-focused on the launch. Our initial attention is going to be under patients with the highest unmet need, and that includes the refractory, multirelapsing and poorly-controlled patients and these steroid dependent patients. There are approximately 14,000 patients who meet these criteria, and they also reflect the patient population that we studied in the RHAPSODY Phase III trial. The primary reason to focus on these patients at launch is the fact that they have the immediate, highest unmet need, and they're also the easiest to identify, and they provide a clear call to action for physicians to prescribe. That said, we do believe that the data from RHAPSODY as well as the physician experience over time could broaden the utilizations to patients with a single recurrence associated with a risk factor such as cardiac tamponade, effusion or constriction. And that will be a decision, however, between the physicians and the patients, and our promotional efforts will be within the FDA-approved label. Slide 10 will remind you of the robust data that we had from the pivotal Phase III RHAPSODY study. And that poses in great stead as we continue to prepare for the potential launch. Both the primary efficacy standpoint and all major secondary endpoints were highly statistically significant. We had a hazard ratio of 0.04 and a p-value of less than 0.0001. And ultimately, there was a 96% reduction in the risk of a recurrent pericarditis event. And thanks to the well-tolerated safety results and the weekly dosing regimen, we believe that rilonacept treatment has the potential to make a meaningful impact on the lives of patients suffering with recurrent pericarditis. Our launch strategy is focused on 4 main strategic imperatives, and you'll see that on Slide 11. At a high level, we are focused on building disease awareness and credible relationships with the key stakeholders and those are the patients, the physicians and the payers. And if approved, we believe this will drive the adoption and patient access of rilonacept. The current price of ARCALYST is $20,000 a month, and that's based on its weekly administration for CAPS. And we believe this is in line with other specialty biologics that have breakthrough therapy designation and orphan drug destination and reflects the high unmet need in recurrent pericarditis. In terms of duration of treatment, our assessment is driven by market research and which are consistent with the Phase III data set, are that patients could be treated for 6 to 9 months. And for some patients, the treatment duration could be longer, could be 12 months or longer. Slide 12 provides details of our sales force strategy. We believe approximately 70% of our target patient population is concentrated around 800 practice settings. We plan to address this opportunity with a specialty cardiology sales force of just under 30 sales representatives. At launch, each salesperson will initially target the top 10 to 15 accounts within their territory. And that'll account for around 45% of the recurrent pericarditis patients. And this focus should help us enable rapid uptake and adoption. And within the first year, the focus of the sales team will be to expand to the remaining accounts in their territories. In addition, they'll be supported by our team of medical science liaisons, who have already developed strong physician relationships and led disease education efforts with the top accounts. Now on to Slide 13 and moving to the rest of the pipeline, which we're also really excited about. Mavri is a GM-CSF receptor inhibitor. And the first indication we've been evaluating here is giant cell arteritis or GCA. This is an inflammation of the medium to large arteries and can lead to permanent blindness. And we're also evaluating Mavri in severe COVID-19 pneumonia and hyper inflammation. As I mentioned earlier, last year, we announced positive Phase II data for Mavri in GCA, and you'll see that on Slide 14. With this upstream inhibition of 2 pathways, which have both been implicated in giant cell arteritis, Mavri has the potential to provide differentiation by addressing the underlying pathophysiology of the disease. Late last year, we were thrilled to report that both the primary and the secondary efficacy endpoints in that trial achieved statistical significance. There's currently only one approved therapy for GCA, and we believe there is still significant unmet need and commercial opportunity for a safe and effective therapy, particularly as a steroid-sparing agent. Approximately only 1/2 of the relapsing refractory patients are able to achieve sustained remission within 1 year of starting treatment with the current standard of care. So clearly, there's still a need for therapies that could provide a safe and long-term sustained remission in this patient population. Slide 15 and moving on to our valuation of Mavri in COVID-19 pneumonia and hyperinflammation, we previously presented data from an open-label treatment protocol in Italy as well as an investigator-initiated study in the U.S. And this slide shows that data from the U.S. investigator sponsored study, which, by the way, demonstrated similar trends of decreased mortality and lower duration of mechanical ventilation in patients treated with Mavri was as it was seen in the Italian treatment protocol. And this data further support the continued valuation, and we're conducting a seamless Phase II, Phase III trial in severe COVID-19, and we expect to have data from that Phase II portion of the trial in the first half of this year. Slide 16. Mavri has already generated data across 3 different indications to date. In addition to the data for GCA in COVID-19, Mavri was previously studied in over 550 patients with rheumatoid arthritis through Phase IIb studies in Europe. And it's important to note, it is the only anti GM-CSF antagonist to date that achieved prospectively defined primary endpoints of efficacy and safety through Phase IIB. The totality of this data is highly encouraging, and it highlights the potential of the molecule across a host of immune-mediated diseases. And we really look forward to providing further information and next steps for Mavri in the first half of this year. Moving on to Slide 17 in Vixa. Our lead indication here is prurigo nodularis. This is a devastating chronic inflammatory skin disease characterized by pyretic nodules, for which there are currently no FDA approved therapies. Vixa is a first-in-class mechanism that targets OSMR beta, which, by the way, mediate signaling of both IL-31 and oncostatin M. And these are the 2 key cytokines that are implicated in pruritus, inflammation and fibrosis. And we believe this dual mechanism represents a unique opportunity to provide differentiated efficacy in the treatment of prurigo nodularis and various pyretic, inflammatory and fibrotic conditions. Slide 18 provides data from our successful Phase IIa study in prurigo nodularis. We saw that the dual mechanism offers the potential for pruritus relief and nodule improvement. The study met its primary endpoint in a placebo-controlled study, and that was such a significant reduction in weekly average worst hNrs from baseline at week 8 in the Vixa recipients. And there's also a disease severity benefit shown, which was a statistically significant percentage of Vixa recipients achieving an IGA score of either 0 or 1 at week 8 compared to the placebo recipients. And you can see the pruritus relief and nodule improvement on the right of that Slide 18. As you'll see from Slide 19, we're currently enrolling and dosing patients as part of the Phase IIb trial of Vixa in prurigo nodularis, and this is across a range of once-monthly dosing regimens. This study is expected to enroll approximately 180 patients, and each patient will be randomized to receive Vixa or placebo subcutaneously once monthly. And the primary efficacy endpoint is percent change from baseline in the weekly average worst hNRS at week 16. I am really happy to talk to you about our CD40 program now called KPL-404, which you'll see on -- starting on Slide 20. This is a monoclonal antibody that inhibits the CD40, CD40L interaction. And we believe it's a highly attractive molecule for blocking T cell-mediated B-cell driven autoimmunity. And importantly, Kiniksa owns the vast majority of the economics for this program. Slide 21 shows the encouraging preliminary Phase I data we announced just this past December. All the dose escalations occurred as per protocol with no dose-limiting safety findings. All 6 subjects dosed with the 3 mg per kg IV showed full receptor occupancy through day 29, and this corresponded with complete suppression of the T-cell dependent antibody response to the challenged antigen called KLH, and that was also through day 29. And there was a consistent dose relatedness shown in the lower dose cohort and the data collection for the higher doses is still ongoing. As I mentioned, we were really pleased to get this preliminary data, and it certainly supports additional evaluation in patients, including potentially monthly IV or subcutaneous administration. Moving on to Slide 22. On the basis of that preliminary Phase I data, we began the process of disease indication selection for KPL-404. The CD40, CD40L interaction has been implicated in diseases such as rheumatoid arthritis, Sjogren's, Grave's, systemic lupus and solid organ transplant, where the external proof-of-concept has been demonstrated. As you can see on that slide, KPL-404 has the potential to make an impact in multiple diseases, including first-in-class opportunities, as well as derisked or fast follow-up opportunities. So 404 has the potential to be a best-in-class molecule across a broad range of autoimmune diseases, and we expect final data and safety follow-up from all the dose cohorts from that Phase I study in the first half of this year. So now turning to the next and final slide. At Kiniksa, we are very focused on building the maximum value across our portfolio. And the fact that we have multiple programs gives us a tremendous amount of optionality to allocate capital relative to the opportunity for the benefit of patients and shareholders. It's a very exciting time at Kiniksa, we're on the cusp of our first potential commercial launch. Rilonacept has the potential to become the first FDA-approved therapy for recurrent pericarditis, and we're committed to bringing this potential treatment option to patients as fast and as effectively as possible. We want to continue to be energized as we are by all our programs and all our progress across the entire portfolio and we believe that we're well positioned to execute throughout this year and beyond. Importantly, we are very well capitalized, and we have cash reserves that are expected to fund our current operating plan into 2023. Ultimately, we want, and we're working really, really hard every day to achieve massive success for patients. And with that, Anupam, I'll turn it back to you for the Q&A session. Almost 20 minutes, I think.

Well, thanks so much. Sanj, do you want to introduce the broader team, Kiniksa team on the line?

Absolutely. I think they're joining now. So we have John Paolini, who's our Chief Medical Officer; we have Eben Tessari, who's our Chief Business Officer; Mark Ragosa, who's the Interim Chief Financial Officer; and Ross Moat, who's our Head of Commercial for rilonacept. So welcome, guys. It's about time you did some heavy lifting here. Let's have one.

Yes. We'll start out with rilonacept in recurrent pericarditis. You talked about the PDUFA in March, March 21. So what are the key sort of market access initiatives ongoing internally, like how do we think about pricing? You talked about product positioning a little bit, but any more color on that, maybe the physician adoption curve, those types of metrics, how do we think about that?

Yes. Maybe, Ross, I'll start with the pricing question and then just all the things that we're doing internally, and maybe you can drill down to a bit more detail. So first of all, the price of ARCALYST is set at $20,000 a month, as I said earlier, and that's based on the weekly administration in CAPS. And based on the unmet need and the breakthrough therapy designation and the fact that this program really is a specialty biologic, we don't see a need to deviate from that pricing strategy. Internally, we have been building our commercial infrastructure initially with this medical science liaisons, as I mentioned earlier, we've had those in place for a couple of years now. They've been working with the key physicians around disease education. But we've also built a value access and payer organization as well. We have our sales heads in place, and they've been working with the payers. But maybe Ross, you can sort of elucidate a bit further and go into a bit more detail.

Absolutely. Thank you very much, Sanj. So yes, we remain very excited by the potential launch. At a high level, we're focusing on building disease awareness and credible relationships with the key stakeholders, the patients, physicians and payers. If approved, we believe this could drive the Board adoption and patient access for rilonacept. We actually initiated early payer engagement some months ago, focusing on disease understanding, our pipeline and the top line RHAPSODY results. And payers have been very receptive. And as a reminder, ARCALYST has been approved in both CAPS and Dara to rare genetic diseases and is already covered by the vast majority of payers. We expect this may allow for an exceptional review, quite typical of line extensions until full coverage policies are put into place. And our objective is for the majority of payers to establish coverage policy within 6 months of the launch, and almost all payers have updated coverage policy within a year. We really expect payers that will implement policies that are consistent with the information in our final label. And you asked about, put our position in and physician adoption. I mean we believe that with the compelling data that we have from RHAPSODY as a Phase III pivotal study, rilonacept really has the potential to become the standard of care in recurrent pericarditis. Maybe as a reminder, we have identified that there are approximately 14,000 patients with the highest unmet need. And this provides us with a very focused, targeted launch with a very clear call to our action for physicians, to really support patients, if approved in prurigo nodularis.

And what does your market research suggest about the potential duration of therapy for rilonacept in the recurrent setting? What is known about the duration of therapy with anakinra in the recurrent setting as a comp?

Yes. I mean, in terms of duration for rilonacept, our assessment, which is informed by market research and consistent with the pivotal Phase III data set is that treatment duration could be approximately 6 to 9 months. Additionally, we know that some thought leaders may recommend treatment duration of 12 months or more, enough of the inflammatory process to be sufficiently arrested in some patients. And in RHAPSODY, the median duration of rilonacept was 9 months, ranging up to 15 months when the blinded portion of the trial closed. After which, patients seemed willing to stay on therapy, as 74 out of 75 of the patients rolled into the long-term extension portion of the study, wanting to remain on rilonacept, which could be seen as an indicator for patient satisfaction and outcomes. As you mentioned about anakinra, I mean anakinra is not approved in recurrent pericarditis. Furthermore, perhaps associated with that, physicians and patients have low awareness and usage is extremely low. Where rilonacept, on the other hand, if approved, really could set the bar for the standard of care in recurrent pericarditis as the only FDA approved therapy, offering a well-tolerated weekly subcutaneous dosing regimen as well as a compelling value proposition.

And then maybe switching gears a little bit to Vixarelimab, the Phase IIb study that initiated in mid-December and PN. How do we think about sort of the enrollment curve there? And when might we get some more granularity on time lines to data for that?

Yes. I mean, we don't typically comment on enrollment. But as you said, we have begun enrolling and dosing patients as part of that Phase IIb dose-ranging study. As with all our trials, you just look at the history, I mean, even during the [indiscernible] of the pandemic, we met our enrollment time lines for all the other programs, actually beat them in some cases. And so as with all the trials, we were very careful to make sure we design in a way that there can be remote data collection, while the assessments that are being done can be done from home for the patients and not having to have them go into census. Maybe I'll let John comment on the sort of proactive things we've done, but we don't comment enrollment. Clearly, once we've enrolled it. And once we have some data, we're going to be looking forward to sharing that, particularly on the heels of the Phase IIa study that we had. But John, any comments on all the things you've done to proactively make sure we get this trial done as fast as possible?

Absolutely. Thank you, Sanj, and good afternoon, Anupam. So certainly, with the trial that's currently rolling in this current environment, it these measures are in place, in fact, to allow for the treatment of a really debilitating disease. And so in that sense, the patients really have a need to see their clinician. And often since these studies are handled, were thought leaders, they're our experts, this is -- these centers usually have the appropriate precautions in place. Maybe a little bit of word on the design of the trial and the kind of information that we hope to gain from the trial. Sanj mentioned the trial design briefly in his talk. This is a dose-ranging trial with 3 different monthly subcutaneous dosing regimens of Vixarelimab, and those can be dosed at home. And so it's 180 patients with moderate to severe prurigo nodularis, who are experiencing severe pruritus. Primary efficacy endpoint is percent change from baseline. The weekly average worse to NRS at week 16. And of course, we want to look to find a minimally effective dose level within a practical monthly dosing subcutaneous regimen. And importantly, again, because of the severity of this disease, we're looking for the proportion of patients who could achieve a score of 0 to 1 in the PN-IGA score at week 16. That's a measure of change in the V severity, which based upon the speed of the IGA response you saw in Phase IIa, could potentially speak to the dual mechanism of action, including the OSM axis. So maybe I'll pause there for the next question.

Yes. And then what are the range of scenarios we should be thinking about for Mavri and GCA in terms of next steps for the program, as you look at the GCA landscape, what are the pockets of unmet need where Mavri could really drive a lot of value.

Maybe, Eben and John, you guys can tag-team that, I know you both, been heavily involved in that?

Yes. John, why don't you start and then I can hop in with any other context.

Absolutely. So we believe that there is a significant unmet need for safe and effective therapies in giant cell arteritis. And that's really because only about half of the patients can achieve sustained remission annually with current standard of care. These patients are usually treated with steroids, and often for years, 50% to 70% of patients have disease recurrence when the steroids are weaned. And as you know, there's 1 FDA-approved therapy for giant cell arteritis. This is an adjunct to steroids. Sanj mentioned, in his talk that we believe that doesn't fully address the underlying cause of inflammation. That's because that therapy is working really downstream only after the inflammatory cascade has been activated. And in fact, that limitation becomes particularly evident if you look at patients with relapsing refractory disease. Now with regard to mavrilimumab in the GM-CSF pathway, we've shown data over the past 2 years that this cytokine appears to drive GCA pathophysiology from the upstream through these 2 downstream pathways. And our [indiscernible] data with human arteries showed that in addition of GM-CSF with mavrilimumab suppresses those cytokine pathways, including gamma interferon. So our Phase II data that we showed at ACR in 2020 affirmed the mechanism of action of mavrilimumab and GCA, but also the magnitude of the clinical effect in the pools population is encouraging. It's supportive for further clinical development. And that's evidenced by the statistical significance of the trial endpoints, as Sanj mentioned, in the pool population but also those consistent trends for reduced flares and greater sustained remission rates in both the new onset and the relapsing refractory populations. So in terms of the next steps, that's really informed by discussions that we're going to have with the FDA. And so of course, that guidance on potential next steps would be expected in the first half of 2021.

But it sounds like you're -- it sounds like you're open to going into a broad population versus a naïve or only relapsed/refractory setting, right?

The clinical trial data showed evidence of benefit and reduced flare rates as well as increased sustain remission in both of those subpopulations. We agree that -- and in fact, there is an unmet need in both of those populations. And so there's -- we would expect the pool population to benefit in that sense.

Matt, I think Matt from the team is going to ask a quick question.

Yes. My question relates to next steps for Mavri in COVID. So you've got the Phase II/III study ongoing, Phase II data in the first half. Just wondering if there's a path to EUA on the Phase II data? And if not, what's the path to market?

Yes. Maybe I'll make a few comments, and John, you're welcome to [indiscernible] and jump in amid. I mean, it's still really big data dependent. Obviously, we were highly encouraged by the initial Italian treatment protocol as I said earlier, as well as the U.S. investigator sponsored study, which matched that, showed improvements in the mortality and the reliance on mechanical ventilation, albeit in small patient numbers. But this Phase II, Phase III trial is obviously much bigger. It is a seamless Phase II, Phase III design. We will have data from the Phase II portion in the first half of this year. And I think depending on that data, Matt, I think you're absolutely right. I mean we're an aggressive bunch. And clearly, there's a need out there even with vaccines being available, there's clearly a patient population that's going to require this type of therapeutic. So depending on that data, we'll certainly be thinking about our next strategic steps. But John, anything to add on that?

No, I think that's exactly right. I mean we can -- if you'd like, we can talk a little bit more about where therapeutics fit into the overall armamentarium that physicians might have at their disposal as you think through the prevention paradigm, all the way through to the treatment paradigm. And I think that's especially of note because of -- even with, let's say, broad scale vaccinations, we still think that there are substantial populations who either don't get vaccinated or who nevertheless develop the disease. And then when we think about where the antiviral therapies and the antibody cocktails fit in, those work, really only if given in the early stage of the disease, and that's during the period of active viral replication. So what we're talking about with mavrilimumab is really in the treatment of patients with the hyperinflammation syndrome. And that's really a maladaptive host response, and that's usually after the viral infection has been cleared. And so in that sense, we think that there's still an unmet need for targeted immunomodulation in those patients who are presenting with acute pneumonia syndromes and respiratory failure. And that's why the totality of the data with mavrilimumab to date continue to support the continued evaluation of mavrilimumab in the disease and the potential utilization in next steps.

Maybe a final question here, maybe on KPL-404. The data from all the cohorts are expected here in the first half. Just wondering how those data would factor into sort of push-pull levers as you think about indication selection for 404?

John, do you want to take that one, or Eben?

Yes. So maybe I'll start with the data from the trial and then hand it over to Eben to talk about how these fit into the competitive landscape, and some of the disease selection. So just a quick reminder from Sanj's talk that the data that we showed in December of 2020 really replicate and extend our preclinical data with favorable PK profiles. And importantly, beyond just safety and PK, really demonstrating target engagement through receptor occupancy and pharmacodynamics with target engagement. And we have some of the data to date through the 3-milligram per kilo IV dose, and the critical outcomes measure is that there is full receptor occupancy through day 29, and that corresponds with complete suppression of the TDR response to antigen challenge to KLH at day 29, with being well tolerated to date. So that really supports the subsequent study in patients. We have 2 more cohorts to come with data, the 5-milligram per kilo subcu and the 10-milligram per kilo IV. Those completed dosing, and we're completing the sampling PK sample collection. So that information will really help us determine the appropriate dose and dose interval to take forward into patients as we continue forward. But Eben, maybe you want to handle the piece of the question around the competitive landscape in potential diseases.

Yes, sure, absolutely. So Phase 1 trial's still ongoing, so we'll have to collect all the rest of that information. But to date, what we've seen is highly encouraging. So the landscape certainly has a handful of competitors in it, although, in our view, the evolution of this mechanism and in that landscape, shows that historically and traditionally, subcu development has been a little bit of a challenge, with molecules either having antidrug antibodies, which is exactly counter to the mechanism of inhibiting IgG formation to neoantigens or whether they've failed trials due to PK variability or not having high enough exposure. And due to our high concentration liquid formulation, along with, alongside the data we've been able to generate to date has really put us what we believe in to be a quite beneficial position in a potentially best-in-class molecule for a broad range of autoimmune diseases.

Okay. Sanj and team. I want to thank you guys so much for a super-productive session, and I hope you guys have a great evening and a great rest of the conference.

Thank you very much. We're excited. Thank you.

Thank you. So thanks, everyone, so much.

Thanks.

Thank you.