Robert Blum: Yes. So good on you for noting that those guidelines dropped just today, I will ask Fady and Andrew both to comment from their perspectives in light of your questions. And you did get a green out of Diane, by the way.
Fady Malik: Well, I saw the guidelines drop in my inbox two hours before this call and actually didn’t see that until the middle of this call. So just — I’ll do my best to answer your question, which having scanned them briefly. I think they — number one, they are preferring to a class of myosin inhibitors and — nothing really surprising, I would say. They followed toward the same approach that the EMA, the ESC guidelines did kind of placing cardiac myosin inhibitors as following first-line therapy of beta blockers. So these are patients who fail first-line therapy like that that’s why we are conducting MAPLE potentially to show that there are advantages to starting cardiac myosin inhibitors first. And hopefully, those data will inform future guidelines.
There are some specific things where they conflate issues with cardiac myosin inhibitors that are actually compound specific and not cardiac myosin inhibitor specific. I won’t delineate those, but I think if you read them, you’ll figure that out, and so some of that may in the future need to be sorted out, and we’ll just have to do our best to ensure that, that information is in the hands of the people who do the guidelines. We certainly weren’t aware of what was in the guidelines. We don’t participate in that process, but we can make sure that the data is available to them. And I expect…
Andrew Callos: I’m sorry.
Fady Malik: Go ahead, Andrew.
Andrew Callos: Yes. The only thing maybe I was going to add to your question was around the guidelines. Certainly, that’s credibility when talking to physicians around evidence that certainly adds credibility to payers to cover, especially if it’s a first-line therapy. Additional studies certainly give more strength to a guideline as well. And I think probably extremely important is, it’s a guideline, as an example, talks about, say, first-line therapy because of data like MAPLE having that data and that evidence. And being able to talk to physicians about it as compared to not having that evidence and not being able to talk to physicians about it, I think is a big difference. So I think the guideline helps maybe to summarize with credibility to various stakeholders and probably most importantly us as a pharmaceutical company talk to physicians and payers about the evidence relative to aficamten if we get approved.
Carter Gould: Thank you.
Operator: Thank you. Our next question will come from Yasmeen Rahimi from Piper Sandler. Your line is open.
Yasmeen Rahimi: Thank you, team, for all the great details. I guess as we’re going into the Cardiology Heart Failure Congress here on Monday. You have spoken about how the more you look at the data, the better it gets. Do you think on — like, I guess, the question that people have going into Monday, data release or full data disclosures around it is — will it become even more clear that aficamten wins on efficacy, not only just on its safety product profile. I would love to kind of get your color around that, and I’ll jump into — back into the queue?
Robert Blum: So to be clear, we did not conduct a head-to-head comparison of aficamten with mavacamten and it would not be appropriate to imply that we did. With that said, we believe the profile of aficamten in SEQUOIA as it relates to efficacy, safety, convenience and all those things that factor into its next-in-class profile will be supported by the evidence as would be indicative of our belief that aficamten can become the cardiac myosin inhibitor of choice ultimately, if approved. With that said, that’s ultimately for you to determine once you see the data — the results will be available not just in presentations, but in publications and not just at the European Heart Failure meeting, but throughout other meetings later this year. And I do believe that these results are reaffirming of our expectations.
Yasmeen Rahimi: Thank you so much. Looking forward to Monday.
Robert Blum: Thank you.
Operator: Thank you. Our next question comes from Akash Tewari from Jefferies. Your line is now open.
Unidentified Analyst: This is Amy on for Akash. Thanks so much for taking your question. Just one on CK-586. Do you think the drug will need out LVEF monitoring? And what are you seeing in your healthy volunteer data that either supports or doesn’t support this requirement? Thank you so much.
Robert Blum: I’ll maybe take that one. I think we developed CK-586 and as potentially the mean to dose this in FF patients without echo monitoring — routine echo monitoring. That said, we need to produce the data that eventually supports that, and I think it’s premature to know for sure whether we’ll achieve that or not. The profile that we saw in Phase 1 was contributory toward that. And so we’ll know more as we explore this drug more in Phase 2.
Unidentified Analyst: Got it. Thanks so much.
Operator: Thank you. Our next question will come from Serge Belanger from Needham. Your line is open.
Robert Blum: Hello Serge.
Serge Belanger: Hi, good afternoon. Hi, good afternoon, Robert. You’ve had two meetings with the FDA so far and another one coming up, I guess, later this quarter. What are your current thoughts regarding the potential for a priority review or in the ADCOM? Thanks.
Robert Blum: Yes. So neither of those are in our base case assumptions, we believe that as a next-in-class profile, it would be more exceptional to assume priority review. It’s certainly possible, but that’s not something that we’re banking on, so to speak. And as it relates to an AdCom, we don’t expect one, but 1 can be surprised by those things. And for the fact that the data are, we believe, quite compelling. There’s already very effective cardiac myosin inhibitor on the marketplace that did not have an AdCom. I think it would be unusual to now have an AdCom for a next-in-class compound. But I guess it’s theoretically possible, it’s not our base case assumption.
Serge Belanger: Thank you.
Operator: Thank you. Our next question will come from Ash Verma from UBS. Your line is open.
Ashwani Verma: Thanks for taking our questions. I have to – so regarding just the presentation on Monday, like from your perspective, what do you think is the bar for the LVEF less than 40% event from the SEQUOIA study. What level of LVEF less than 40% would give you the conviction that the FDA could actually indeed be discerning in viewing your safety profile as differentiated from Camzyos? And then second, on the OSCM market, just in the long run, do you think fundamentally, there is a lot of diagnosis expansion that you could drive OSCM investors, and that has seen pretty significant diagnosis expansion? Just if you can frame what’s the difference between the two? Thanks.
Robert Blum: So I might ask Fady to speak to the comments about ES below 40, but recognizing our top line press release already speaks to some of those matters.
Fady Malik: Yes. I was going to say that as we said in our top line that we didn’t have any treatment discontinuations for EF less than 40%. And the protocol mandated those if they were observed at the site. We’ll expand on that in the presentation, I suppose. But again, I don’t think 0 or 1 is going to be any — all that contributory, if you will. Things that don’t happen are good to know, and they’re certainly supportive of the safety profile. We’ve never had an event of heart failure due to aficamten and treatment interruptions have been almost nonexistent. And so I think, overall, those are all very promising things with regards to the potential labeling down the road. And I don’t think we understood your second question, which I guess will entertain.
Ashwani Verma: Yes. Just like quickly, I mean, in terms of like just the diagnosis expansion of oHCM right, I mean, 1 could argue that, yes, it has a high unmet need, but the mortality and mobility burden is not as high as something like AQR has seen a significant diagnosis expansion. So do you believe that in the long run, you could potentially drive a lot of diagnosis expansion? I mean, Bristol been doing a lot and other marketing campaigns still not driving any kind of a meaningful inflection on Camzyos. So just trying to understand if this oHCM market is sort of where it is? Or could we see like a material expansion in the long run?
