Conixa at Goldman Sachs Conference: Strategic Growth and Innovation

On Tuesday, 10 June 2025, Conixa (NASDAQ:KNSA) participated in the Goldman Sachs 46th Annual Global Healthcare Conference, emphasizing its strategic advancements in the treatment of recurrent pericarditis. The company showcased its robust revenue growth and innovative pipeline, while addressing potential challenges such as tariff impacts and evolving market dynamics.

Key Takeaways

• Conixa increased its annual revenue guidance to between $590 million and $605 million.
• The company highlighted the potential of KPL-387, targeting a 2028-2029 launch.
• Manufacturing of Arclis is shifting to Samsung Biologics, with minimal tariff impact expected.
• Conixa reported profitability in Q1 2025 with a cash balance of $268 million.
• The prescriber base for Arclis has grown to over 3,150, with increased therapy duration.

Financial Results

• Revenue Guidance: Conixa raised its revenue expectations for the year to between $590 million and $605 million.
• Q1 Growth Drivers: Key factors included a rise in prescriber numbers, extended therapy duration, and the Medicare Part D redesign.
• Prescriber Growth: The total prescriber base expanded to more than 3,150, with 26% prescribing to multiple patients.
• Profitability: The company achieved profitability in Q1 2025.
• Cash Position: Conixa holds a cash balance of approximately $268 million.

Operational Updates

• Arclis Performance: The prescriber base increased, and the average treatment duration rose to 30 months. A significant portion of patients restarting therapy do so within 8 weeks.
• Commercial Strategy: Conixa is employing a targeted approach, leveraging both field force and digital marketing to expand its reach.
• KPL-387 Development: The Phase 2/3 trial is set to begin in mid-2025, with Phase 2 data expected in the latter half of 2026. The trial will focus on demonstrating efficacy in pain and inflammation reduction.

Future Outlook

• Innovation Commitment: Conixa aims to continue innovating in the recurrent pericarditis market, with plans to launch KPL-387 by 2028-2029.
• Market Expansion: The company plans to target approximately 25,000 potential prescribers, including cardiologists and rheumatologists.
• Pipeline Development: KPL-1161, an extended half-life IL-1 pathway inhibitor, is being developed for other chronic diseases.

Q&A Highlights

• Medicare Part D Impact: The redesign has made treatments more affordable, but its long-term effects remain uncertain.
• Patient Behavior: There is an increasing trend towards using Arclis as a monotherapy, with more patients starting treatment after one recurrence.
• KPL-387 Differentiation: The drug’s potential for monthly dosing and its monotherapy goal are key differentiators.

For more detailed insights, readers are encouraged to refer to the full conference call transcript.

Full transcript - Goldman Sachs 46th Annual Global Healthcare Conference:

Paul Choi, Biotech Analyst, Goldman Sachs: Thank you. Good morning, everyone. I’m Paul Choi. I’m a biotech analyst here at Goldman Sachs. It’s my pleasure to welcome Conixa for our session this morning on the day of the conference.

I’m required to read off certain disclosures, which primarily relate to investment banking relationships that Goldman Sachs may have with firm, companies presenting here at the conference. These relationships include, investment banking, a 1% or more ownership, and other, relationships. These relationships are available through our disclosures available on our research portal website available to you as as clients of the firm. I’m prepared to read them out loud. However, they are, again, available on our research portal.

So with that, we’ll continue. And with Conixa, to my immediate left is Ross Mote, head of commercial, and by far left, John Paolini, chief medical officer. Maybe what we’ll do is either let Ross or John maybe kick it off a little bit with an overview of of Connexa, sort of where the company’s background and sort of core core focus is, and then we’ll get into some, more substantive, Q and

Ross Mote, Head of Commercial, Conixa: A after that. Wonderful. Yeah. I’m happy to do that. Thank you very much, for hosting us today, Paul, and and the Goldman Sachs team.

So, we’re happy to be here. We will be providing some forward looking statements today, which are subject to risks and uncertainties, full copies of which can be seen in our SEC filings and on our webpage. And I’m here joined with doctor John Paolini, our chief medical officer. I’m Ross Modes, chief commercial officer. Maybe just to provide a quick, yeah, corporate overview to begin with.

As you know, Paul, we we are a growth orientated, well capitalized organization. We are focused on addressing unmet needs, particularly within the cardiovascular space. We’re a commercial stage organization, with a good portfolio in the clinical stages as well. Arclis, which was approved in 2021, has been growing nicely since the time of our launch, in 2025. In fact, our Q1 earnings call this year, we increased our revenue guidance for this year, to between $590,000,000 and $6.00 $5,000,000.

So Arcus is is really performing pretty well so far, but we’re very excited about the opportunity we have ahead, and I’m sure we’ll go into more details in the subsequent questions. We also have an advancing clinical, portfolio, in particular, in a fairly recent announcement of just last week, is with KPL three eighty seven, which is into the clinic in, in recurrent pericarditis. And this is a monoclonal antibody, which is the potential for a liquid formulation, potential for an auto injector, and potentially to be a monthly preparation. So an exciting new patient for recurrent pericarditis patients. And that’s initiating in a phase two, three clinical study in the mid twenty twenty five time frame with data readout for the phase two portion of that study in the second half of twenty twenty six.

So we’re pleased with how that’s advancing. We also have KPL eleven sixty one, which is an even longer acting, interleukin one alpha beta inhibitor, and again, a monoclonal antibody, which has undisclosed, indications, so far, but we’re advancing that through, IND enabling, studies. So with that, maybe I’m happy to take a pause, and we go into the questions that you have, Paul.

Paul Choi, Biotech Analyst, Goldman Sachs: Sounds good, Ross. Maybe talking a little bit about last quarter and maybe the intra quarter trends to date here. One of the things you noted on the first quarter earnings call was the impact of the Medicare Part D redesign. Some other companies have commented on this that this has been a tailwind for their franchise, seems to have had a similar effect on yours. Can you maybe just talk about how has this helped in the Arcelis Medicare, I guess, eligible population?

Are they going through their coverage and donut holes quicker than they have in the past? Any just sort of comments or color there would would would be helpful.

Ross Mote, Head of Commercial, Conixa: Yeah. Thank you. So, yes, we did talk about that a little bit, the q one earnings call, and that’s really associated with the the IRA, and the the Medicare Part D redesign associated with that, which essentially, increased the affordability for patients, for Medicare Part D patients with a cap on the co pays, an annual cap of $2,000 and the ability to spread the costs throughout the year as well. So we did know that Q1 had pretty significant growth versus Q4 of last year, and that was driven, really by three key factors. One was an increase in prescriber base.

We saw an increase in around 300 prescribers, new prescribers to our list in recurrent pericarditis, taking our total to around 3,150 or more. And that was actually one of the largest growths that we’ve had, quarter to date. Given the fact we’ve been on market for four years, I think shows the trajectory that we’re on, and what we still have left to do. So that was kind of one lever. And another lever was increased durations of therapy, which we saw grow from an average of around twenty seven months to now an average of around thirty months, in total average duration of therapy on ArcLis.

And thirdly, as you mentioned, the Medicare Part D redesign, that did enable, you know, kind of a one time bolus of of patients who were previously on, free goods, and obviously they’ve had treatment already before switching over onto commercial drugs. It’s not as if they are necessarily new patients. So in the main, they’re not new patients to Arclis, but they transitioned across from free goods to commercial. And that’s associated with the redesign and the increased affordability for those patients, to go on to commercial therapy. So, we were pleased with that since it was added meaningfully to the Q1 numbers.

Quite how that plays out through the rest of the year is is somewhat uncertain. As I say, these patients

Paul Choi, Biotech Analyst, Goldman Sachs: The year of the redesign.

Ross Mote, Head of Commercial, Conixa: So Yes. The year of the redesign. Absolutely. You know, there is a grace period for these patients. There are, you know, levers for whether these patients kinda pay their bills or not with their payers under this new redesign.

And so I think one element is those patients that transitioned across, will they act like kind of other patient cohorts that we see or not? And time will tell on that one. And then additionally, for new patients coming into the funnel that are Medicare Part D patients, again, we we need to see how that kind of plays out under this new new program where the the co pay, you know, will be a maximum of $2,000 regardless of when they start throughout the year. But, obviously, as you get further through the year, if they’re spreading their costs evenly over the remaining months of the year, the monthly payments kind of ramp up as as the year goes on. So having said that, these patients may also be on other therapies.

And remember, this cap covers all of their Medicare Part D patients. So there’s there’s some kind of uncertainties there. We’ll have to see how it plays out.

Paul Choi, Biotech Analyst, Goldman Sachs: Yeah. I think one of the questions is is that because of the lower $2,000 cap, whether it’s just been a pull forward of that, I think, in the front half of the year, and now patients are just paying their minimal co pay on on the forward here for both your drug and and other drugs. I’m also curious as you think about you talked a little bit about the increase in duration, but has there been any other observable changes in patient behavior over the last, call it, twelve months in terms of beyond duration, any time to restarts and and things like that, people coming on off drug but then on drug quicker? Any any color there you can provide on patient behavior.

Ross Mote, Head of Commercial, Conixa: Yeah. Thank you. So I think there have been certainly changes, and and things have evolved over time. I think not least just the fact that, you know, since Arclis being on the market, think the viewpoint of both from both health care professionals and patients has been changing towards this disease, primarily, you know, understanding it in greater detail as a as a generally a multi year chronic disease for most patients. And I think we’ve seen that, you know, kind of play through in the treatment duration of of ArcLIST as well.

So the total duration of treatment has been growing quite rapidly really since the time of our launch. If you remember in the early days, we anticipated that maybe, you know, the duration will be six to nine months and it kind of grew to twelve months, eighteen months. Now we’re at thirty months as an average total treatment duration. The initial treatment period has has grown somewhat as well. The the median for the initial treatment period is around seventeen months now.

The restart rate is still about the same. It’s been around forty five percent of all patients who stop therapy do come back on to therapy, and those patients generally come back on within around an eight week time frame, which makes sense when you think about the washout period and the pharmacodynamics of the of the drug. And if you still have underlying auto inflammation ongoing and you withdraw the drug, which is helping to prevent recurrences, it would make sense that within around an eight week time period is when patients, you know, start to suffer symptomology again if there is underlying auto information ongoing. And then the good news is they can go back onto drug, you know, very, very easily usually. Usually there’s a payer approval in place.

Often the patient has drug on hand or they just get their next fill, and can go back onto therapy. And then what we are starting to see is that as patients come back onto therapy, now we’ve got patients, you know, we’re four years out from launch, we’ve got patients who have stopped and started multiple times now. So we rather than providing, you know, precise information on all of those kind of restarts and so on, we just aggregate it up as a total duration of therapy, taking out all the stop time periods, and that’s what gets you to around the thirty months.

Paul Choi, Biotech Analyst, Goldman Sachs: Great. I’m also curious. You you talked about the in the prescriber base last quarter as well. And just where is this traction coming from? Is it still primarily in cardiology focused academic centers, or is it more in the community practice?

I’m just curious how the how the blend of prescribers has evolved over time as well.

Ross Mote, Head of Commercial, Conixa: Yeah. So it’s continued to grow very well. So we’ve got more than, 3,150 total prescribers now. Out of that group, we’ve got around 26% or around 820 prescribers who have written for two or more patients. So that’s continued to grow kind of really pretty nicely every single quarter since launch.

And when you overlay that sorry. Excuse me. When you overlay that with the, with the total number of potential prescribers that are out there, you know, there’s around 25,000 cardiologists and rheumatologists as well, it shows that there’s still an awful lot of people that could be switched on to prescribing. Bear in mind that these patients are, you know, pretty widely spread throughout The US, and there has been, somewhat of a change in the treatment landscape with the evolution of more centers of excellence popping up, really taking a keen interest in pericardial diseases per se. So that’s kind of maybe increased some throughput at those centers.

But, generally, patients are are pretty widely spread, so there’s a lot more physicians to Okay. To switch on for this disease.

Paul Choi, Biotech Analyst, Goldman Sachs: You mentioned what you you think the prescriber base is of about roughly 25,000, physicians out there. I guess just where are you in terms of apologies for the sports metaphor, but what inning are you in in terms of targeting that and at least hitting your your call points at least once with that sort of initial target base of prescribers? You talked about, you know, 3,000 plus already writing scripts, but just in terms of at least hitting the, the call points, where where are you now?

Ross Mote, Head of Commercial, Conixa: Yeah. Thank you. So we we just haven’t provided much of the details around the metrics of our, kind of commercial team and the the call points and call rates and that type of thing. Maybe suffice to say that we are, incredibly targeted and well disciplined as an organization. We spent an awful lot of time in fact, prior to the launch and, of course, we’ve learned a huge amount since launch as well to really understand the nuances of where patients present, which physicians, whether it’s cardiologists, rheumatologists, and how that interlink works, and really kind of mapping whether where we believe the patients are.

So we’ve we’ve done a lot of work to make sure that we are very well targeted from both our field force perspective and where we cover and what our call rate needs to be on, you know, the highest deciles, if you like, of doctors that are out there, but also working very smartly with the kind of the long tail of physicians who may only see, I don’t call it one patient per year, but it’s still very important to reach those doctors. So we find ways of doing that. If it’s not through the field team, we focus very much on digital marketing and then PP type of promotion, nonpersonal promotion, to make sure we get messages out to, you know, as many people as we possibly can. Yep.

Paul Choi, Biotech Analyst, Goldman Sachs: I’ll let you get a set. But in in the meantime, my question is, you’ve talked about this duration of treatment increasing continually as as as the drug has been on on the marketplace to what seems to be more like a a maintenance treatment. But I’m just curious, how is Arcelis thought of as an acute treatment versus steroids, let’s say, in in the emergency room or or cardiologist office. Is it is it resonating because it’s symptomatic relief and that’s what’s driving the the maintenance? Or just maybe help us understand how how the patients are continuing to stay on drug here.

Ross Mote, Head of Commercial, Conixa: Yeah. It’s a really great question. It’s one of the key things that we’ve been focused on since the time of our launch in that, historically, I think recurrent pericarditis was seen as kind of different individual flares and physicians will be focused on treating the individual flares of the disease. And I think the mindset is now and with as the data has evolved, has has really now come through to an understanding that this is a chronic multi year disease in most patients and particularly for those patients who suffer two or more, incidences and the disease has a median of three years, a third of the patients are still suffering after five years, a quarter of the patients are still suffering after eight years. So this disease really persists, substantially for for many, many patients.

Now physicians would use to, really try the individual, flares and and kind of improved symptoms, associated with the disease. NSAIDs and colchicine have always been a mainstay, particularly of an index episode of pericarditis. And as it gets through to for those patients that continue to suffer recurrent pericarditis, often corticosteroids were utilized. And, often, you know, knowing the corticosteroids were the toxicity effects and it being incredibly difficult to take patients off steroids without them re flaring again and even elongating the disease, there’s now been more of a movement to, okay, this is a multi year disease and Arclis has been designed to be treated throughout the duration of the disease. It has really two key parts to the label.

One dramatic relief and the pain improvement and the reduction of inflammation markers, but very, very importantly and what we hear is actually, you know, one of the most important things for both physicians and particularly for patients is the prevention of future recurrences. These patients are often terrified of suffering future recurrences, not knowing when it’s going to happen, not knowing, you know, the cadence and the severity of future recurrences, you know, really limiting their ability to travel, their ability to do things that they may want to be doing. And that quality of life element has been very important to patients. So I think that’s really where Arclis fits in very nicely, that it is used for the treatment for the prevention of future or the reduction of the risk of future, recurrences happening for these patients. So with the, you know, the knowledge that this is a multi year disease, the fact that Arclis has now been used as an average for thirty months, I think bodes well.

There are still questions of, you know, when do you stop treatments? That is somewhat of a, you know, kind of informed by baseline characteristics, but also it’s a little bit of trial and error of not fully knowing or having a very robust way to understand whether the patient is through the disease or not. So sometimes when physicians and patients decide to trial a stop of ArcLIST, it’s thinking that hopefully they’re through the disease but you don’t really fully know until you stop therapy. You withdraw alkalis and you see whether the patient flares again. Yep.

Paul Choi, Biotech Analyst, Goldman Sachs: I’m curious as the as as you gather more data and more patient experiences over the over the past few years, Are patients primarily still going on after two plus flares or recurrences, or are you starting to see more of the patients come after their recurrence? Just curious how the sort of patient history or patient mix has evolved.

Ross Mote, Head of Commercial, Conixa: Yeah. We’ve certainly seen more and more patients in in Ensys come on on the recurrence, if you like. So we’ve stated that we have around, if you take all the recurrent pericarditis patients and when we’ve done research with those patients and with the physicians as well to ask what stage were the patients at when they were prescribed ArcLISS, around fifteen percent of all those patients were started when they were on their recurrence and eighty five percent on two or more recurrences. So I think that shows that there’s been, you know, Arclis, as people become more and more comfortable with it and it’s the only FDA approved therapy for recurrent pericarditis, more and more people have become very comfortable with prescribing the drug, how to prescribe it, getting patients onto therapy, the prior authorization and so on. And I think that’s led to greater confidence of prescribing it earlier on in the disease.

But I think the incredibly important point is one way of looking at it is how many flares does a patient have. But actually, Arclis is the the label is agnostic to the number of flares a patient has suffered. So as long as it’s recovering pericarditis, a physician can use it, for those patients under the under the label. So probably the more apt way of looking at it is what line of therapy is Arclis prescribed in. And generally, what we’ve seen in both the literature, which has really been coming out more and more since the time of launch, and in prescriber behavior, is that Arclis has now really been used before corticosteroids, I think to an increasing level as people become more and more familiar.

So generally after NSAIDs and colchicine, which are used for an index episode, and then physicians are more and more coming to Arcalis as the next line in therapy.

Paul Choi, Biotech Analyst, Goldman Sachs: One of the things the company has talked about is shifting manufacturing of Arcalis to to a party. I think Samsung Biologics specifically. Can you maybe walk us through the rationale to behind your diversification of sort of manufacturing plans? And then secondly, just given that policy considerations and foreign manufacturing is so topical these days, just sort of what the potential impact to you from a maybe from a margin perspective or roughly might be from, having having a foreign manufactured Arcelis?

Ross Mote, Head of Commercial, Conixa: Yeah. Thank you, Paul. So, this is really something that we’ve had planned under the the license agreement with Regeneron since the the beginning stages with with Arcelis. And a tech transfer was triggered in 2023, so we’ve been working on the technology transfer for some time with Regeneron support. Right now, Arclis is manufactured in The US under Regeneron.

So that would, know, if you think about tariffs and so on, obviously, Arclis right now, would not be subject to any, you know, potential tariffs. Of course, there’s uncertainty there of exactly what things, you know, may look like in the future. But as we go through the technology transfer, which is to, South Korea, we expect at some point in the future as drug kind of comes in, of course, not knowing really what the tariffs may look like, if they exist at all, if they’re extended to pharmaceuticals or, anything in the future. But if if indeed it is extended to pharmaceuticals and there’s a tariff on bringing, you know, drug in from South Korea, we expect that to be immaterial, to our gross margins. We’re importing drug substance from South Korea to to our US, not finished product.

So we believe that any such tariffs would be likely to be, levied on on drug substance. We should have an immaterial impact to Conix’s margin. Okay.

Paul Choi, Biotech Analyst, Goldman Sachs: With the fill and finish still to be done in in The US? That’s correct. Okay. Great. I wanna maybe bring John into the conversation, talk a little bit about three eighty seven here.

He’s been very patient. And as you think about three eighty seven and and the properties that that it has versus versus Arcalus, to maybe compare and contrast sort of the key properties and sort of what you think the incremental benefits might be with with three eighty seven as you advance it through the clinic.

John Paolini, Chief Medical Officer, Conixa: Yeah. No. No. Thanks for that, Paul, and thanks for having Yeah. We’re excited about the KPL three eighty seven program.

As as Ross had mentioned, that as a monoclonal antibody in a liquid formulation with subcutaneous administration, the prospect, or the possibility of having a single injection with a monthly, dosing interval profile, is something that, you know, could provide, really a nice option for, patients and physicians in the treatment of this disease. I think as we think about that, you know, as Ross mentioned with the growing understanding of the duration of the disease being, you know, median of three years as you start to think about, you know, how patients might wish to treat the disease having a monthly profile for successful with that, you know, could really be, beneficial to them. But I think the way we view this is that, physicians and patients should have a range of options available to them, and then each option, if you will, you know, has to present present itself and, and speak for itself, in terms of those attributes. But, we’re very excited about this program, which is, you know, just starting, scheduled to start in the, middle of this year for the, phase two three program that we recently announced, and we can go through that.

Paul Choi, Biotech Analyst, Goldman Sachs: Great. Apart from a potentially more convenient dosing interval, are there any other properties of three eighty seven that might translate either from a efficacy or or a safety perspective at this point?

John Paolini, Chief Medical Officer, Conixa: Right. Well, certainly, ARC List has set the bar in terms of what a highly efficacious approach to blocking the IL-one pathway, you know, can do. And and again, we point out that it’s important to block both IL-one alpha and IL-one beta in order to maximize, the inhibition of the mechanism, and to make sure that know, the kinds of treatment response and reduction in risk of recurrence, you know, to to to have that maintained. So that’s a very high bar, if you will. I think, you know, I wouldn’t sell short the the the importance of the dosing interval.

So I think at this point, it remains to be seen, exactly what the efficacy of KPL three eighty seven, you know, will be. We’re certainly, well positioned, to do the appropriate testing and experiments, in order to see, what kind of efficacy and safety profile KPL three eighty seven will bring. But at this point, I think, you know, we know, what that profile would need to look like in order for it to

Paul Choi, Biotech Analyst, Goldman Sachs: be successful for patients. You recently laid out in a in a press release the sort of trial parameters, and and maybe you could remind the audience of how you’re thinking about advancing it through the clinic, sort of what what key metrics matter from from a from a trial design and pivotal endpoint perspective?

John Paolini, Chief Medical Officer, Conixa: Sure. No. Thanks for that. Yeah. So we’ve previously mentioned that our phase one data that had shown that subcutaneous dosing could support a monthly profile.

And recently we shared that a little bit more of the specifics that the three hundred milligram, subcutaneous dose, can be delivered in phase two in a single injection, provides extensive exposures above the target threshold for, you know, fifty six days plus, so therefore supporting a paradigm of monthly dosing. So as we thought about the phase two three program, as you would expect, we drew upon our our extensive, trial design experience with, with Rhapsody exactly, which, for others is the phase three program that supported, the SBLA for for Arclis back in 2021. And so we took a lot of those learnings, forward as we thought about how to design this program. And, of course, with the goal of speed to bring this to patients as quickly as humanly possible, the approach that we took is a phase two three program design. So that’s taking a phase two dose focusing portion, a phase three pivotal portion, two long term extensions, all in overlapping, you know, for format, but all integrated into a single protocol.

And so that is scheduled to start in the in the mid portion of this year. And so maybe a little bit more detail. The dose focusing portion, patients who are experiencing acute pericarditis episode despite oral therapies, you know, are brought into the trial and randomized in a one to one to one to one ratio across four different dosing levels of KPL three eighty seven with that primary efficacy endpoint of time to treatment response, and that’s a twenty four week treatment period. And after that’s done, patients may be eligible to continue on receiving treatment with additional durations of exposures for twenty four for an additional twenty four months. Once the phase once the dose focusing portion, you know, is completed, then the pivotal portion can begin in an overlapping fashion.

And that’s a classic randomized withdrawal program with a with a run-in period, the duration of which is blinded, followed by a randomized withdrawal period, which is event driven. And so, again, when that portion of the study is closed, patients can continue into a long term extension. That entire package, the way it’s designed, as I mentioned, with starting in the middle of of this year, the phase two data would be expected in the second half of twenty twenty six. And in terms of the overall program timelines, you know, Sanj has mentioned that, in in previous meetings that we wanna bring this forward to patients in the ’27, ’28 I’m sorry. We wanna bring this to patients in the 2829 time frame.

And so, as we think about the the timelines going forward, you know, we’ve engaged with the FDA, and so we’re on track to begin the program, and we’re excited to move forward. Great. Maybe one question on

Paul Choi, Biotech Analyst, Goldman Sachs: the trial design is I think in rhapsody before the dose focus portion of it, the analogous portion there, there was a bit of a taper period off their existing therapies or background therapies. Is is that the case here as as well too?

John Paolini, Chief Medical Officer, Conixa: Right. So the the goal of we we believe that

Paul Choi, Biotech Analyst, Goldman Sachs: Steroid taper, I think it was. Yeah.

John Paolini, Chief Medical Officer, Conixa: Yeah. No. That that that’s perfect. We believe that the, the way because of the mechanism of the disease, that targeted immunomodulation of the IL one pathway is sufficient, for the managing of the disease. And so that those learnings which we had from the, from the rhapsody program are carried forward into this program even as early as the phase two program, where the goal is to demonstrate the efficacy of KPL three eighty seven as a monotherapy.

And so in the phase two program, patients initiate therapy and then are tapered off their, standard oral therapies, and then that carries forward into the phase three program, as well where, there’s a broader, list of prior therapies the patients can come in on. But, again, the goal is to achieve monotherapy with KPL three eighty seven throughout the program.

Paul Choi, Biotech Analyst, Goldman Sachs: One follow-up question I have is on the eligible pop population here. You you had a pretty well defined patient population for for Rhapsody. Are the inclusion or exclusion criteria basically the same here for for for this phase two, three study? Or are you thinking about possibly a a more expansive population that might allow you down the road to to tackle a a broader patient set?

John Paolini, Chief Medical Officer, Conixa: Right. So in terms of inclusion exclusion criteria, one thing to note is that clinicaltrials.gov is a very is our is a very excellent resource, if you will, for updates of our clinical trials. And in fact, the trial is in fact posted on clinicaltrials.gov right now, and so it does have the inclusion exclusion criteria, at least the top level ones, for the patients. It’s also important to note that a lot of times the inclusion exclusion criteria are a little bit more about, the efficient running of a clinical trial. If you look at the ArcoLess label, what you see is that, you know, we we had the inclusion criteria that we did, but the label, itself is very broad.

So as Ross mentioned, for example, it’s agnostic to the number of recurrences. It just says, you know, recurrent pericarditis. It’s agnostic to, prior treatment. It’s agnostic to, the etiology of the original disease. And so those learnings are carried forward into this program, as well where we target the specific populations that are necessary for the execution of the trial and the and and shall we say the robustness of the endpoints of the trial, but with the ultimate understanding that the biology speaks to that broad population as as as you’ve described.

So in that sense, patients entering the trial who have recurrent pericarditis have any etiology except for the forbidden etiologies, As you might expect, you know, cancer, and certain, infections, you know, can, enter the trial. The idea of the acutely symptomatic patient entering the trial is there in order to be able to demonstrate that part of the label that Ross mentioned, which is, you know, the the treatment, of the disease, meaning the reduction in pain and the reduction of inflammation and the control of the manifestations of the disease. And so in that upfront portion, that’s an important part of it. And then, you know, ultimately, the demonstration or the reduction in risk of recurrence, that’s where the randomized withdrawal portion comes in and the demonstration of the recurrence of the disease, you know, as the drug washes out with the introduction of the placebo. And then the rescue of the patient once they’ve had a recurrence that meets a bailout criteria and demonstrating that that patient goes back under control is really part of that, totality.

So I think we have the right patient population that’s in the trial Mhmm. And the the the patient attributes, if you will, that support the robust endpoints of the trial.

Paul Choi, Biotech Analyst, Goldman Sachs: So we know that IL-one has been validated as a target from an efficacy perspective, but just curious, maybe more at a theoretical level from the longer exposure or continual exposure to to it, to three eight seven? Just what are the theoretical, I guess, safety risks that that could happen with with a longer or more continuous exposure here?

John Paolini, Chief Medical Officer, Conixa: Sure. So it’s always it’s always a benefit risk. And the Arclus program demonstrated that complete pathway inhibition, you know, of of IL one alpha and IL one beta is is very well tolerated. The, you know, the we carry in the in the label for ArcoLIST the potential risks of, you know, of course, the injection site reactions that are, you know, of course, in the in the near term with the injection of the drug, but in terms of the the longer term in terms of infections, you know, the which usually manifest itself themselves in terms of upper respiratory tract infections. But it’s important to note that this is a targeted immunomodulator.

So when you think about that in the context of other options that previously had been available to patients, which were corticosteroids, which provided broad based immunosuppression, you know, I think, what the program the previous program has shown is what the profile of a targeted immunomodulator could be. So as we roll forward and think about the KPL three eighty seven program where the difference is instead of targeting the cytokine and trapping the cytokine, which is what Arcolyst does, to targeting the receptor, which is what KPL three eighty seven does. You know, our expectation is that, you know, mechanistically, these would be, you know, you know, fairly similar. But, of course, as with any program, it’s necessary to, you know, go through the the the program, you know, in its totality in order to demonstrate Yep. The safety profile and the benefit risk.

And as I mentioned, the reason why we’ve described such a robust program of, you know, over a 160 plus patients, with not only these two studies, but also the two long term extensions, you know, really provides a robust platform to collect the kind of, safety data and benefit risk data that will help inform physicians as they’re making that choice with their patients.

Paul Choi, Biotech Analyst, Goldman Sachs: Great. We’re running close on time, so maybe I wanna end on one more question, which is just as you think about life cycle management for the category, you you’re developed you have three eighty seven in clinic now. You’ve also talked briefly about one one six one as as as a as another asset. Just, you know, how are you thinking about life cycle management here and transitioning from a a partnered asset where you with our in the case of Arcelis with Regeneron versus these these proprietary assets and just positioning your your evolving portfolio.

John Paolini, Chief Medical Officer, Conixa: Mhmm. Well, may maybe I’ll say a little bit about, you know, kind of from the scientific perspective and then turn it over to Ross. So just to mention a little bit about November, which Ross mentioned in his introductory remarks. So this is an extended half life IL-one pathway inhibitor, again blocking IL-one alpha and IL-one beta, and it does that with Fc modifications. And so that is an option for us as we think about, you know, a range of chronic diseases that, you know, that are mediated through the I l one pathway.

So not necessarily restricted to recurrent pericarditis. And I think what we have to do as that program moves forward is really think about, you know, what is the best place for for diseases that, you know, would potentially benefit from management with a with a quarterly drug. But, know, Ross, I don’t know if you wanna comment a bit more about the interface of the other assets.

Ross Mote, Head of Commercial, Conixa: Yeah. Absolutely. Thank you. So yeah. And so we’re excited by the future.

And I think, you know, as market leaders within recurrent pericarditis, it’s upon us to make sure we continue to innovate and provide treatment options for patients suffering what’s a really debilitating disease. Arculus has got incredibly, strong efficacy, and is a very well tolerated drug as as John has has taken us through. We believe Arculus has a huge potential ahead as well. As a reminder, at the end of twenty twenty four, we were around thirteen percent penetrated into just the 14,000. That’s a two plus recurrence thousand, popular population.

So that tells us that there’s significant room left, for us to continue to grow, ArcLIST in recurrent pericarditis. At the same time, as I said, you know, upfront, we are, you know, a well capitalized, growth orientated organization. We are planning for the future. We want to make sure that we dominate this, disease space and continue to provide the options that the patients need. KPR three eighty seven is a wholly owned, independently developed, drug that we’re very excited about.

And then one one six one is kind of behind it, not necessarily in recurrent pericarditis, but has optionalities. Maybe just to finish, you know, the organization was profitable in q one of twenty twenty five thanks to the growing Arclis revenues, which added to our cash balances of around $268,000,000. So we’re well capitalized and very excited about the future that we have.

Paul Choi, Biotech Analyst, Goldman Sachs: Great. My thanks to Ross and John for joining us, and we’ll end it on that note. Thank you very much.

John Paolini, Chief Medical Officer, Conixa: Thank you, Ross. Appreciate it.

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