Kiniksa Pharmaceuticals, Ltd. (NASDAQ:KNSA) Q1 2024 Earnings Call Transcript

And so that ability to do Abiprubart as a subcutaneous drug rather than intravenous drug in these rheumatologic diseases and then to be able to spread out the dosing in the whole, so you test not only biweekly dosing, which is pretty standard, but even to stretch it out to potentially monthly dosing, which would be relatively unique in this space to have monthly subcutaneous dosing to us gives us a lot of confidence as we go forward into the Sjögren’s study that Abiprubart has the opportunity, we have the potential opportunity to show differentiation across other assets.

Paul Choi: Great. Thank you.

Operator: And thank you. And one moment for our next question. And our next question comes from David Nierengarten from Wedbush Securities. Your line is now open.

David Nierengarten : Okay. Thanks for taking our question. I had two. So, maybe following up on the Sjögren’s kind of competitive landscape is. I was curious who you considered your main competitor and if as a sub part of that how predictive do you think the rheumatoid factor is reduction for symptom relief in Sjögren’s? And then a quick question on ARCALYST. I mean, it seems obvious, but just checking that that the physician kind of paradigm seems to be shifting to Aspirin maybe Colchicine in the frontline kind of recurrent pericarditis setting for the majority of patients and then ARCALYST, is that, is that a fair characterization of the market shift? Thanks.

Ross Moat: Yeah, hi, David, this is Ross. Maybe I’ll start with the ARCALYST one and then I could hand over to Eben on COA for the Abiprubart question. So, yeah, I – just to summarize, I think that’s a fair characteristic. I think you said for patients that first of all suffer from pericarditis are generally treated with NSAIDs and not the Colchicine as well often when they come back and then recurrent patients, it’s often the same treatment regimen, but with for the longer duration. And then obviously we are focused on patients go on their second recurrence or more and making sure that ARCALYST is really the standard of care of choice for those patients. At that time, they are clearly being the current patients and suffered from the disease and going to break it through the usual early therapy options and really requiring something that targets the recurrence of the disease.

So, yes, we think that’s the way we’re seeing it and as John shared with the RESONANCE Registry, we are certainly starting to see those key physicians focused on recurrences of the disease utilizing ARCALYST ahead of corticosteroids, which again is addressing the physicians that we are aiming for. Eben?

Eben Tessari: Yeah, hey David [Indiscernible] Thanks for the question. So we often look at the better landscape with a broad lens and follow all of the programs currently in clinical studies and producing data. Maybe to narrowly answer your question looking at the CD40-CD154 antagonist class alone, there are three others that have either produced results or are studying their asset ratio versus these those are the horizon now Amgen molecule [Indiscernible] which is currently rolling in a Phase 3 study with a IV formulation. There is Iscalimab from Novartis which has finished the Phase 2 program with five weekly subcu dosing. Both of those programs have demonstrated specifically significant efficacy in this population, which give us a lot of confidence going into this study that we’re in the right patient population to potentially demonstrate an efficacy.

And then the third program is a safety program called for Iscalimab which has been studied in Sjögren’s suppressing [Indiscernible] with no results reported as of yet. And I think where – given the data we generate today with 404, we’re pretty excited about our study and the ability to test not only exclusively a subcutaneous formulation, but also testing at biweekly and also monthly.

Operator: And thank you. And one moment for our next – one moment. And our next question comes from Geoff Meacham from Bank of America. Your line is now open.

Geoff Meacham: Morning guys. Thanks for the question and congrats on a good quarter. Ross, just on ARCALYST, you’ve had a successful launch so far, but obviously raising awareness I suspect will be key. So, are there plans to publish RESONANCE? And are there other studies that you guys were thinking about in terms of raising the profile? And then second question for Sanj, you’ll obviously be investing in Abiprubart going forward, but you guess have committed to remaining cash flow positive. So I guess the question is how important is profitability or pipeline expansion from us on a strategic basis relative to your commercial investments in ARCALYST? Thanks guys.

Sanj Patel : Thanks, Geoff. John, do you want to start?

John Paolini : Absolutely. Thanks Geoff for the question. Yeah, we’re really excited about the RESONANCE Registry, because that’s really an important tool by which we’re learning about recurrent pericarditis epigenealogy and disease management. And importantly there are more than 20 centers across the US that are led by cardiologist investigators who have a focus on recurrent pericarditis and these are really the leading edge of managing the disease. So in that sense, the data serves as an example for other clinicians around the country who are seeking to grow their knowledge base. So, this is what we’re looking to do and as we’ve done in the past is this is a five-year registry and we’re kind of right in the middle of it right now.

So about halfway enrolled, about halfway through the follow-up period adding patients all the time we’ve presented at prior scientific meetings and we just presented at the American College of Cardiology and there’s a lot of information in this registry that we hope to harvest as we go forward and gaining a lot of insights about it. In this time around the fact that we learned about the penetration of IL-1 pathway inhibition as a concept and then importantly that these evidence-based cardiologists are adopting a steroid-sparing paradigm in the treatment of the disease meaning that other movements from the NSAIDs and Colchicine directly to IL-1 pathway inhibition and that’s really been driven by ARCALYST and that’s been a growing trend year-on-year.