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Conference · 2026-09-09

Kiniksa Pharmaceuticals International, plc (KNSA) September 2026 Conference Transcript

Concluded Sep 9, 2026 Audio replay
Sep 9, 2026 35:39 39 turns
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2026-09-09
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35:39 Audio
Operator

Great. So, welcome to the next session of the Wells Fargo Healthcare Conference. My name is Valfortea. I'm one of the biotech analysts on the platform. And we have with us today, Ross Mote, COO and John Paolini, CMO of Kinexa. Thanks so much for being here.

Ross Moat COO

Thank you very much. Very happy to be here, Ava. Thank you.

Operator

Perfect. So, maybe we can start with a quick overview of Kinexa, you know, past 12 months, next 12 months before we jump into questions.

Ross Moat COO

Certainly happy to. Thank you very much, Ava, and thanks to everyone in the room for joining us and everyone online for listening in. So we're very happy to be here, and thank you for the hospitality and the meetings that we have set up today. John and I are here from Conixa. We will be making some forward-looking statements which are subject to risks and uncertainties, a full copy of which can be found in our SEC finance. Maybe if I start with a high-level overview of the organization, and then we can dive into whichever part of the organization you'd like to, Ava. So, Canixer is a well-capitalized, growth-orientated organization. Excuse me. We have been around for around 10 years now as a company. We've been a commercial-stage organization for just over five years with ArcList in recurrent pericarditis. ArcList is doing very well commercially. In Q2, we announced net revenue of around $243 million, which is one of the largest quarter-on-quarter growths. In fact, the largest quarter on quarter growth that we've had launched to date. And we feel like we're still relatively nascent in that market with a substantial opportunity left to help more and more patients. So we're very pleased with how our list is going. And we increased our net revenue guidance for 2026 for the full year to between nine hundred and eighty and nine hundred and ninety five million dollars. behind the commercial asset we also have a pipeline of drugs which are progressing rapidly at different stages into the clinic and through the clinic so we have kpl387 which is being investigated in recurrent pericarditis we announced just a couple of months ago some of the phase two data for that which is the dose focusing portion of our total studies and we're pleased to say that we move forward with the target product profile into the phase three, which is the monthly subcutaneous drug, which will hopefully be in an auto-injector formulation in recurrent pericarditis. So not only did we announce that data around the phase two, but also that we have initiated the phase three study and already dosing and enrolling patients in the phase three study. Behind that, we also have KPL1161, which is an FC-modified drug, which could go into different indications that are IO1-mediated, of which there are many. And this is potentially a quarterly drug, which, again, is focused on the inhibition of IO1-alpha and beta. So the organization is well capitalized. We have around $525 million in cash reserves at the end of Q2. and have historically been profitable, and we're very excited about the future. So with that, maybe we'll dive into the questions, Eva.

Operator

Perfect. Lots of things to ask about. Maybe we can start with our list. Kind of like, you know, revenue continues to exceed expectations despite already being standard of care. So, you know, what are the biggest drivers of growth at this point? Like, has the launch started to mature, Or are you still do you still expect like year over year growth that's exceeding expectations?

Ross Moat COO

Yeah, it's a great question. So we certainly think that there's a lot of growth opportunity left within this marketplace. And there's several ways of of looking at that opportunity, whether it's by the number of patients or the number of prescribers. We can go into some of those metrics. But ultimately, you know, we feel like we're relatively nascent and making good progress. But there's a lot to do in this marketplace. And I think one by one, we're making progress. and we're switching on more and more physicians to this new way of prescribing and treating patients with recurrent pericarditis. The literature is also being populated with a new paradigm of how to prescribe and how to treat this disease, which we're very pleased with. And ultimately, as we've announced before, we're around 21% penetrated into the population that's two or more recurrences. So you'll know if you've been following Kinexa for a while that the recurrent pericarditis population is around 40,000 patients and that's the indication for archaeologists but if you subdivide that into the number of flares a patient has suffered and you look at those that are in two or more recurrences that's a 14,000 population out of the 40,000 we're about 21 percent penetrated at the end of 2020 sorry at the end of Q2 of this year into that population of the 14,000. So that's without even accounting for the larger number of patients that are on the first recurrence and within label which is an additional 26,000 patients. So I think that tells us that you know to get to 21% we've been making good progress. Clearly there's an awful lot more to do within the two plus recurrence group and we're getting growing utilization in the first recurrence group as well and physicians ultimately you know making the decision that they don't have to wait for their patients to suffer future flares before treating them earlier on in the disease with targeted interleukin-1 alpha and beta inhibition.

Operator

Got it. Very helpful. And you mentioned, you know, second quarter, highest quarter of new patient enrollment since launch. What's driving this acceleration?

Ross Moat COO

Thank you. So I think there's a lot of things is kind of multifactorial, all the things that we're focused on as an organization and how we've been involved in this marketplace. So some of those things are, as I mentioned earlier, around the population of data in publications. We've always been promoting ArcList since the time of launch, five and a bit years ago, as a therapy which is steroid sparing, which is one of the things that physicians used to reach towards to treat this disease, really through lack of other treatment alternatives. And the population now, or the populated data, is really showing that physicians should be using interleukin-1-alpha and beta prior to corticosteroids, so after the utilization of NSAIDs and colchazine prior to corticosteroids to opt for interleukin-1-alpha and beta inhibition. That's how we've been promoting it since the time of launch and has aligned with our data. and as I think more you know physicians kind of understand that and get the message in through dissemination of the data and particularly through the ACC concise clinical guidance which was published midway through last year in August of last year which affirms that type of treatment paradigm. I think more and more physicians are coming on board with that and recognizing the new way of treating the disease. So certainly publications and just experiencing the marketplace of this evolving treatment paradigm are certainly helping. Obviously, our field execution continues to be incredibly important. We're very focused upon that from obviously a commercial viewpoint, but also from a medical affairs viewpoint around data dissemination and progression within the marketplace of the understanding and the knowledge of not just recurrent pericarditis, but of ARKLIST and how to prescribe the drug. and then additionally we've also invested and worked heavily in DTC and AI as well you know very targeted fashion so for DTC which direct to consumer kind of don't think of the you know the historic big pharma big spend type of DTC campaigns but more things that are very focused and targeted for rare disease populations where you can work to try to identify patients that are suffering from the disease and serve up relevant adverts, particularly to that household or that patient population, to inform and educate and empower patients to go and speak to their physicians about recurrent pericarditis and arc list. So that's something that we've embarked upon from earlier this year. We've started to see some good successes through. And we think that level of empowering patients to go and speak to their physicians is very important because when you ask or when we asked patients in our market research of their awareness of treatment options for recurrent periconitis, only 14% of patients were aware of ArcList. But when patients were aware of ArcList and they went to speak to their physicians about ArcList, about 80% of those patients ended up with an appropriate ArcList prescription. So we know that by empowering patients, that can make a significant difference to their relevant identification and treatment to really help them with this disease so DTC has been very important for us so far this year and also as I mentioned with AI again we've been utilizing more innovative ways of targeting physicians and thinking through when patients are flaring and which patients will flare and when to go and see physicians so we've moved on from more of a historic way of targeting a marketplace of just identify which physicians to go and see but now more importantly trying to understand when we should be seeing those physicians when it's most appropriate that they most might might be likely to see a recurrent pericarditis patient so we've been evolving um along with the you know the work and the experience that we have within the marketplace now over the last five and a half years and um as we said up to the end of q2 we're quite happy with how it's going but an awful lot left to do.

Operator

Got it. Very helpful. You mentioned the 21 percent penetration at the end of second quarter in this patient population with multiple recurrence. What's the realistic ceiling for this patient population and which constraints bind first? Is it diagnosis? Is it the prescriber conversion? Is it persistence?

Ross Moat COO

Well, I think all of those things are very important. We've never guided forward of what we think the ultimate peak penetration could be into the marketplace. But I I think the 21% of the 2-plus recurrence group tells you that there's significant room left in the 2-plus recurrence group, let alone, as I said, those that were earlier on in the disease in the first recurrence, which are a much larger population. So we think there's significant opportunity. If you also look at it from a prescriber perspective, out of the 40,000 patient population in a given year that are suffering from recurrent pericarditis, they actually interact with about 25 or so thousand physicians mainly cardiologists to some extent rheumatologists and then if you overlay that with the prescriber base of archaeologists so a total of 25,000 physicians about 5,000 of those have prescribed for archaeologists so far so again we've got a lot of education and awareness to do but ultimately we're kind of creating this new wave of how to look after patients for recurrent pericarditis. And one by one, more physicians are taking that on board. And quite where we get to, we don't know, but we're certainly placing huge efforts behind it. And, you know, what you will know hopefully about Conigso is that we will never rest on our laurels. We very much focus on the next thing and how we can get better and better as we continue to grow as an organization.

Operator

Got it. Very helpful. Maybe just touching upon the discontinuation rate and kind of like patient restart. I mean, is there anything about these patients that discontinue and then they restart again that could help predict whether this is going to happen, maybe some specific patient characteristics or reason for discontinuation?

Ross Moat COO

Yeah. So maybe if I provide some high level thoughts on kind of treatment duration and the natural history of the disease. And John, if you've got anything to add around like predictive factors or that type of thing, please add in. So we have seen that the average duration of treatment for archaeologists has grown over time. We know that this is a long disease in most patients, a chronic multi-year disease, often not lifelong, but certainly multiple years for many patients. The natural history studies or the largest natural history study of this disease shows that the median duration of the disease is around three years. And we actually don't know what the average duration of the disease is. This is for patients with two or more recurrences because that largest data set actually ends at eight years. And at that eight-year time point, there was still about 25% of the patients within that large cohort that were still suffering from the disease. So we know that the average is longer, but the median is three years. Now, Arculus was really designed to be used for long term throughout the course of the disease. So if you stop Archelist earlier on in the disease and the disease is still is there in the background and the auto inflammation will come back, then symptomology starts to build up again. The patients know that they can go back onto treatment to get under control again and see through the history of the natural history of the disease. So that's what we've seen over time. We've seen that the disease, that the treatment of Archelist has grown. the median is around three years now for for arc list treatments and whether that grows or not we'll see what happens in the future and around 45 percent of patients that stop treatment go back on to treatments and often that's when they they start because they think they may be through either of their their own volition or through consultation with their healthcare professional that they think they may be through the disease and if they if they're not and symptomology builds back then about 45 percent of those patients go back on to treatment until they think it's the appropriate time to stop again. So generally, that's what we've seen. And John, have you got anything further to add around the risk factors?

Yeah, I mean, I think when you go back all the way to 2018, 2019, and look at how clinicians were treating recurrent pericarditis, they were treated episodically. They would see the flare, they would treat, and they'd say, okay, well, we'll give you six months of treatment, and then we'll stop and see what happens. I think what time has shown is that, as Ross said, now that with this understanding that the disease is longstanding, if you withdraw therapy prematurely, the disease will come back, right? And so now I think where the dialogue has shifted is to how to evaluate a patient at the time of diagnosis or at the time that an expert is seeing this patient for the first time and understand for how long that patient would need to be treated. And so there are risk scores or risk factors that one can use to look at a patient at the time of presentation and use those in order to understand or predict at some level what the likelihood of drug-free remission might be at one, three, or five years. And so when you look at these patients based upon risk, and you can identify that this patient might have three- or five-year disease, that is really very informative to the physician, but also informative to the patient to manage expectations that this is a long-term chronic disease, perhaps not lifelong, but therefore, you know, you may need three years of treatment or five years of treatment. And so that, I think, is leading to a greater continuity of treatment and the idea of treating to the duration of the disease rather than having a fixed duration of treatment that's somewhat arbitrary.

Operator

Got it. Makes sense. And then for these patients that are restarting, are they restarting due to having a pericarditis attack or is it changes in biomarkers or predicting factors that suggest they could have a pericarditis attack in the future?

Ross Moat COO

Yeah. So, I mean, usually it's, you know, when patients do decide to stop treatment with ArcList, usually it's nice that they know that there's a safety net there, that they can just restart ArcList. And we know through the clinical trial data that if you stop and you do suffer a flare or symptomology building back and then you go back onto treatment, you get under control again very quickly throughout the next duration until you think the disease has come to its natural end. And so I think when patients know that, that's a nice thing with their physician that they know they can kind of stop and start as required. And I think, John, have you got anything else to add on that?

Yeah, I mean, I think the trial data show that premature cessation leads to recurrence, and that was a fairly high rate, as you would expect, because these were high-risk patients. I think you have nice data from, you know, from the real world that also shows that that pattern, you know, does in fact carry through as well that, you know, patients who still have underlying disease tend to recur and go back on therapy.

Operator

Got it. Very helpful. I mean, just touching upon the patients in first recurrence, I mean, you previously said about 20% of prescriptions are for patients in first recurrence, 80% multi-recurrence. Is there anything about these patients in first recurrence that kind of, like, helps predict why ArcList is prescribed and how, you know, duration of therapy maybe differs from this multi-recurrence or, like, why are these patients on patient characteristics, stuff like that?

I can say a little bit from the Resonance Registry about what we know about some of these patterns. And then I think you have some data with regard to, you know, use at the time of diagnosis. So with regard to the patient registry, what we have identified is that patients who are on NSAIDs and colchicine, which is the first-line therapy for treatment of recurrent pericarditis, the rate of recurrence is actually reasonably high, one to two recurrences per year while on therapy. Actually, we just showed data at the European Society of Cardiology meetings to this effect. And so what you then see is, you know, of course, for second-line therapy, if you escalate to Rolanicept, the event rates, you know, drop precipitously almost to zero. But what we also showed in that registry is that while there's a small group of patients, what it showed is that patients who were started on Rolanicept at the time of diagnosis, so at the time of their first recurrence. You know, so they essentially burned through their NSAIDs and colchicine at the time of their incident event, got started on Rolanosept, and again, their event rates dropped, you know, well, actually, in that case, they dropped to zero. And I think what it shows is that if you identify patients who are at high risk and are likely to, you know, have long enough disease, longer than, for example, the six months of therapy of NSAIDs and colchicine, which is what's written into the concise clinical guidance, you know, a clinician could actually spare the patient from experiencing that future recurrence, you know, by coming to the end of their NSAIDs and colchicine stopping and then flaring, you know, almost expectantly if you look at the risk factors. So starting them on, you know, continuous IL-1 pathway inhibition with Rolanosept from that point of diagnosis and carrying that out for the duration of the disease is a way of bringing event rates down and creating a better life for their patients. I don't know if you want to comment on what you're saying.

Ross Moat COO

Yeah, exactly. I think what we are seeing since the time of launch of Archelist is that to begin with, I think a lot of the utilization was in the 2-plus recurrence group. Over time, that's shifted a bit. We still have the majority of usage within that group, and we still think that can grow a substantial amount. But over time, and as physicians become more and more confident and comfortable with the drug and how to prescribe the drug and how to manage patients when they're on the drug we have seen growing utilization in that first recurrence group as you said it's around 20 percent of all prescriptions that are now coming in that are within the first recurrence group and 80 they're in the two plus recurrence group and that's that 20 is up from about 15 at this this time last year so we can see the physicians are just getting more comfortable more knowledgeable and using the drug earlier on in the disease And, you know, the information around the risk factors is still, you know, relatively new and physicians are kind of trying to work through that to try to get, you know, more predictive, if you like, of which patients will suffer from what durations of disease so that can guide their kind of treatment decisions and ultimately when to trial and cessation of archivist.

Operator

Got it. Maybe just switching gears to gross to net. I mean, it's been declining over the past several quarters. What has driven this?

Ross Moat COO

Yeah, so the gross of the net year today to the end of Q2 is 7.2%, down from about 8.4%, I think, in Q1 of this year. The main driver of that is ultimately through the co-pays and the co-pay utilization. And we made some changes at the beginning of this year around the co-pay programs to increase the effectiveness and efficiency of our program. So that brought the gross of the net down a little bit. when we were working with AI and some machine learning to try to identify certain patients and their different payer types and how much co-pay was required for those patients for support. And then as you go from Q1 into Q2, of course, the co-pays drop as a lot of patients hit their kind of maximum co-pays, usually at various points within Q1. So in Q2, that had a kind of a slight reduction in the gross to net.

Operator

What we have said historically and still holds true is that usually in q1 is kind of the largest gross to net um and then the pattern kind of drops a bit in q2 q3 and ticks up again a little bit in q4 and that's the historical pattern that we've seen with our list got it and maybe just on the ipn potential future competition i mean how much of the protection from the ipn exclusivity state comes versus you know the the patent protection versus the orphan nature of recurring precarditis versus the complexity of Arculus as a, you know, fusion protein?

Ross Moat COO

Well, as you know, Arculus is a complex protein and a cytokine trap and, you know, complex to manufacture. The IP protection ultimately is with the orphan drug designation and market exclusivity associated with that, which goes through to 2028 and followed with other extensions around the methods of use and so on to 2039 so the IP protection is is very much there but also you know as we've spent a lot of time and knowledge in this marketplace you know really understanding the throughput of patients and the physicians how they think about this disease and everything that we've done to you know really kind of build this marketplace with with Arcalist and to change the treatment paradigm we think there's a you know a lot of knowledge and expertise in what's kind of been done within this marketplace over the years.

Operator

Got it. Very helpful. Maybe just switching gears to KPL 387. You know, as you mentioned on your initial remarks, we got some early data a couple months ago. Maybe can you share with us, you know, what were the key efficacy, safety, and pharmacodynamic findings that kind of supported your move-forward dose?

Sure. So as you know, KPL387, one of the core studies of that is the Phase II-III program, which is a very efficient way of handling development in a seamless way. And so as you mentioned, we reported the results of the Phase II portion or the interval analysis of the Phase II portion, which is a dose-focusing study. So in that study, we had looked at four different dosing regimens. And from there, we selected the 300-milligram once-monthly dosing regimens subcutaneously. And as Ross mentioned, which fits the target product profile of KPL387. And what the data showed was, you know, a rapid onset of action, so a rapid and sustained pain response and treatment response. So that was, you know, in the range of four days, as well as suppression of inflammation with time to CRP normalization of eight days. So that's a very rapid and robust finding with an injectable drug. But then in addition, it showed durability of response, which is another key element that throughout the monthly dosing interval, disease control was maintained. And so with that profile that came from the interval analysis, that is what supported moving forward in our essentially seamless design, the initiation of the phase three portion of the study, pastoral, which is now, as Ross mentioned, enrolling and dosing patients so it's that robust data set that then that fits the target product profile that enables the phase three pivotal study to initiate got it and maybe can you put this data into context you know comparing to arcalist and what we saw on its phase two and like what's to your what's in your view the key point of the key differentiator for 387 so keeping in mind uh always you know cross-trial comparisons you know different populations different different eras but I mean the themes are quite similar right which is the three elements that I mentioned about you know cadence and magnitude of response as well as durability and so in that sense those three elements of the KPL 387 efficacy profile are consistent with what we saw with our coast over the course of you know the development program in phase two and phase three so that's I think the key point is that if you give the drug appropriately in the right amount at the right dosing interval, you can provide sustained blockade, if you will, of IL-1 alpha and IL-1 beta signaling. And so that is the key attribute that you need in order to move forward into the phase three program. And I think the phase three program is designed then to show the efficacy and safety of that regimen, that once-monthly regimen, subcutaneously administered liquid formulation as a total package, and that's what we aim to deliver so that it could be available to patients in the 28-29 time frame.

Operator

Got it. And maybe just talking a little bit through the phase three, this is a placebo-controlled study. What are some of the challenges of enrolling this study, given that ARCALIST is available in the U.S. for patients?

Maybe I'll just say what the design is, and then maybe we can put this in the context of the trial and treatment options. So as you pointed out, so it's a placebo-controlled trial. It's what's called a randomized withdrawal trial. So it draws upon many of the elements, if you will, of the Rhapsody program that was very successful that supported the registration of Arculus. An important element of that is that in this kind of trial design, which is taking patients who are acutely flaring despite standard therapies, it enables all patients to receive active drug in order to bring their disease under control. And then in that randomization portion, while it does allow for the regulatory piece, which is the comparison of active drug to placebo, what it does is it minimizes the amount of time that patients with an active flaring and uncomfortable disease are actually exposed to placebo. And so, you know, in the protocol, there are defined windows for what constitutes basically enough of a signal that then patients can go back onto KPL-387 therapy and put their disease under control and then enable the accrual of long-term efficacy and safety data with regard to control. Now, with regard to enrollment of the trial, this is a global trial. And so we have centers throughout the world. And so treatment paradigms vary, of course, across different geographies. And so this trial is well designed in order to bring in patients regardless or across a spectrum of different background therapies and background therapy histories. And so it enables us to enroll this study, you know, in the U.S. where Arcalist is, you know, currently available as well as other island pathway inhibitors, but also, you know, around the world where, you know, such options may not be available to clinicians. And so in that sense, there are patients around the world who can benefit, you know, from the trial.

Operator

Got it. Very helpful. And you previously mentioned the autoinjector. How critical is the autoinjector to your launch strategy?

Ross Moat COO

And can you just give a sense of where you're at yeah i certainly can i mean it's difficult to say how critical it is but we think it might be a good thing to to add on but we believe there's you know obviously for archaeologists there's a lot of room left for archaeologists but for kpl um 387 we also think having additional treatment options may also be very helpful with a target product profile of a monthly drug um that focuses on what we know are the drivers of this disease which are the two key cytokines of interleukin-1-alpha and beta, we think is very important. If that's going to be in an auto-injector, we think that could also be important. But, you know, when we ask physicians and patients around preferences and think through different target product profiles, including KPL387, ArcList, and other things that are in the clinical realm right now, generally that feedback came back very positive around KPL387, that more than 75% of patients would pick KPL387. Patients that are naive to interleukin-1 alpha and beta treatments said that they would have a higher propensity to start therapy if it was in an auto-injector. When you ask healthcare professionals about preferences, around 92% of healthcare professionals said that they would be highly likely to prescribe the KPL387 profile. So clearly, the profile resonates very well. Now, that has to be backed up with data coming out of the clinic, which we're obviously very, very focused on. But we think that drug could be meaningful.

Operator

Got it. Very helpful. And maybe just on the transition study, can you give us like a quick overview on, you know, what's the objective of the study? What do you hope to learn? And also, you know, patients enrolled in the study have well-controlled recurring precarditis with very specific baseline characteristics. How are these selected and how do you think about, you know, how they correlate with, like, you know, real-world patients?

Yeah, so it actually is a very real-world kind of trial. So this is the transition to KPL387, you know, monotherapy dosing and administration study. So the idea is that you have patients who have well-controlled disease, as you mentioned, some of those specific requirements, and studying the efficacy and the safety of the different regimens that are used to transition patients from whether it's NSAIDs and colchicine or corticosteroids or IL-1 pathway inhibitors, be it anakinra or Rolanosept, and then moving them onto monotherapy with KPL-387. And so the purpose of this study is, it's nothing novel in the sense that we've had to do this before, is to inform how physicians can move from one therapy to another. So, for example, we did this also with Rolanosept. So in the Phase 2 and Phase 3 program, we generated data on transition from NSAIDs and colchicine and corticosteroids. In fact, we published some of that in the Journal of the American Heart Association. And then with regard to transition from anakinra to Rolanoseptata, it was already covered in the label because there was an approval for DERA, deficiency of IL-1 receptor antagonists, where patients were brought to stabilization on anakinra, and then they were transitioned to Rolanosept. And so that posology, if you will, was covered in the label from that study. So essentially, this study is designed in a similar way to provide that information to clinicians of how to move back and forth from therapies. But if you take a step back and think about it in the totality of the program, what this is saying is that we have designed the program around the spectrum of different clinical presentations where patients can present either acutely flaring despite their standard therapies, or they can be well-controlled while on standard therapies. And either way, the development program shows how to transition patients to KPL-387 monotherapy and then maintain them long-term for the duration of the disease.

Operator

Got it. And what's the role of the transition study regarding, you know, the FDA potential approval? Is it, was this something that the FDA requested or is this something that you plan to pursue, you know, to incorporate on label? Right.

So it's not an obligatory study. It's an informative phase two study. And as I mentioned, it's called a posology study, to use a European term, or it's a dosing and administration study in order to provide that information to clinicians so they understand what those different regimens are to make those transitions. In general, that tends to inform either the clinical trial section or the dosing administration sections of labels, and that's our intent is to provide that information to the agency as well as to the literature so that physicians are well-informed at the time of launch as to how to best utilize KPL 387, as I mentioned, whether patients are actively flaring or stable on existing therapies.

Operator

Got it, and maybe during your proper remarks, you mentioned you know different potential indications for 387 and also 1161 and you know potential quarterly dosing there how are you thinking about indication selection and perhaps you know the the pros and cons of like the monthly versus the quarterly yeah i think there's a lot of dynamics there it's something we're you know conscious of and constantly looking at so obviously we have not announced any indication or indications for kpl 1161 at this stage but we are focusing on trying to get that drug into the clinic by the end of this year.

Ross Moat COO

And clearly, there are a lot of IL-1, alpha and beta mediated diseases, some of which have, you know, clinical data and literature behind and others will be more exploratory. But we're definitely, you know, aware of where all the literature is and the diseases that are mediated by that pathway. And we'll announce potential indication at a future time.

Operator

Got it. Maybe just last question. As Kinex approaches sustained profitability, how do you balance the near-term earnings with investing opportunities to create long-term value?

Ross Moat COO

Yeah, it's a great question because obviously everything is important. We're very focused on value and growth as an organization. It's incredibly important to us to stay very focused on Harkless because we think that has huge potential left for the future and has done well up until this moment in time at the end of Q2. But also we're very focused on the rest of the pipeline and bringing through KPL 387 in the Phase 3 study and 1161 into the clinic by the end of this year and ultimately focus on creating value for the future.

Operator

Great. Well, these were all of our questions. Thanks so much for joining us today.

Ross Moat COO

Thank you so much, Eva.

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