Good morning, and welcome, ladies and gentlemen, to Cytokinetics' conference call to discuss the outcome of yesterday's FDA Advisory Committee meeting for omecamtiv mecarbil. At this time, I would like to inform you that this call is being recorded and that all participants are in a listen-only mode. At the company's request, we will open the call for questions and answers after the presentation. We'll allow for one question per participant. I will now turn the call over to Diane Weiser, Cytokinetics Senior Vice President of Corporate Communications and Investor Relations. Please go ahead.
Good morning, and thanks for joining us on the call today. On the call with me today are Robert Blum, President and Chief Executive Officer, who will provide a summary of the advisory committee outcome and implications for the potential approval of omecamtiv mecarbil, as well as Fady Malik, EVP of Research and Development, Andrew Kalos, EVP and Chief Commercial Officer, and Ching W. Jaw, SVP and Chief Financial Officer, who will all participate in our Q&A. Please note that portions of the following discussion, including our responses to questions, contain statements that relate to future events and performance rather than historical facts and constitute forward-looking statements. Our actual results might differ materially from those projected in these forward-looking statements. Additional information concerning factors that could cause our actual results to differ materially from those in these forward-looking statements is contained in our SEC filings.
We undertake no obligation to update any forward-looking statements after this call. Now, I will turn the call over to Robert.
Thank you, Diane. Good morning, everyone, and thanks for joining us on the call. Yesterday, the U.S. Food and Drug Administration's Cardiovascular and Renal Drugs Advisory Committee voted 8 to 3 that the benefits of omecamtiv mecarbil do not outweigh its risk for the treatment of heart failure with reduced ejection fraction or HFrEF. We're disappointed there was not a greater consensus amongst committee members relating to the benefit risk of omecamtiv mecarbil, and we maintain our conviction in the strength of the evidence supporting its potential benefit for certain patients suffering from HFrEF. We continue to believe omecamtiv mecarbil can be a valuable add-on therapy for patients with worsening heart failure who remain at high risk for heart failure events and hospitalization despite being treated with available guideline-directed medical therapy.
While the voting did not go the way we had hoped, we do appreciate the committee's discussion as well as the testimony from the patients, caregivers, advocates, and clinicians who shared their experiences and underscored the need for this important potential medicine. I will remind you that the FDA will consider the recommendation made by the committee in its review of the NDA, but it is not bound to the committee's recommendation. We will look forward to engaging constructively with FDA as it completes its review of the application for omecamtiv mecarbil. I would like to thank our colleagues in clinical, regulatory, biometrics, pharmacology, and drug safety who worked tirelessly in preparation for the advisory committee meeting. Our presentations and engagement with the committee were of the highest quality, and I could not be more proud of the presentations, both as scripted and in response to questions.
Yesterday's meeting enabled us to share our perspective on the data from this program and to hear how FDA and others responded. That is in and of itself a productive step forward. With that said, the path forward for omecamtiv mecarbil is not clear. The discussions at the committee meeting surfaced positives, to be sure, but also issues that weighed importantly on voting. It is still to be determined how FDA will respond to the feedback. The next few months leading into the PDUFA date will be telling, and we commit to keep shareholders informed as much as can be practical given ongoing interactions with FDA. At Cytokinetics, we are not unfamiliar with overcoming challenges, and we certainly have had some with this potential medicine. It's already been a long and winding road for omecamtiv mecarbil, but we do remain hopeful.
We will continue to work with the FDA as it conducts its further review of the NDA. In the meantime, we have contemplated this scenario in our planning, and we will continue to gate certain spending until such time as we have more clarity. As pertains to our commercial preparedness, importantly, I want to remind you that the pre-commercial infrastructure that we built intentionally serves omecamtiv mecarbil, should it be approved, but also lays the groundwork for the potential commercialization of aficamten. As we have purposely designed risk mitigation and synergies into strategies to advance our development pipeline, so too are we looking at our go-to-market strategies and how we would leverage synergies into how we approach those activities. We're not going to elaborate on those matters today, nor will we provide 2023 spending guidance today.
Much like we do every year, you can expect us to provide that information alongside our Q4 earnings in Q1 2023. In the meantime, and this is important, we will look at ways we can extend cash runway as we continue to prioritize the expanded development of aficamten, both in obstructive and non-obstructive HCM. Yesterday's vote does not change that commitment and only adds to the convictions and urgency we feel to advance our science for the benefit of cardiovascular patients. That means a priority in development to aficamten. I hope that in the Q&A that will follow, we can elaborate on those matters, as I know are in particular of interest to shareholders and analysts on this call. Operator, with that, we can now open the call to questions.
Thank you. At this time, we will conduct a question-and-answer session. As a reminder, to ask a question, you will need to press star one one on your telephone. You will then hear an automated message advising you your hand is raised. In the interest of time, we will be taking one question per person at this time. Please stand by while we compile the Q&A roster. Our first question will come from Jeff Hung from Morgan Stanley. Your line is open.
Morning, Jeff.
Thanks for taking my question. Good morning. Thanks for taking my question. You recently announced that the CK-136 phase 1 has begun dosing with patients. Can you just remind us of the potential advantages of 136 over omecamtiv mecarbil? What key learnings can you translate from omecamtiv to 136? Thanks.
Very good question. I'm gonna ask Fady to elaborate on that. For others who may not know, we did announce CK-136 has restarted in Phase 1. This is our cardiac troponin activator. The Phase 1 study is underway, and Fady can speak to its mechanism, how it may relate. To be sure, our focus with CK-136 is not in HFrEF, but in other specialty indications that may read on faster time to market and more specialized cardiovascular indications. Fady?
CK-136 is distinct from omecamtiv mecarbil. It's a cardiac troponin activator, as opposed to myosin activators. Still both are sarcomere proteins and increase the contractility of the cardiac sarcomere. Fundamentally, we developed CK-136 as an alternative mechanism to explore the pharmacology, which appeared to have potentially broader therapeutic index in omecamtiv mecarbil, and potentially larger maximum increases in cardiac function. We are, you know, beginning to explore that in humans now in our Phase 1 study. As Robert said, as we progress the development program, we'll be looking to develop that into indications where there really are no, you know, direct guideline-directed medical therapies, and larger unmet need.
I think from the omecamtiv Mecarbil Program, we've certainly learned potentially how to hone patient population in ways that may advantage us with CK-136.
Thank you, Jeff.
Thanks.
Thank you. One moment for our next question, please. Our next question will come from Salim Syed from Mizuho. Your line is open.
Good morning, Salim.
Hey. Good morning, Robert. Good morning, guys. Sorry, the outcome didn't turn out as you would've liked yesterday. Our sympathies there. I have one question from us, Robert, just on the... Is there any scenario here in your mind as you get more clarity from the FDA, and maybe you can just opine as to what sort of meetings are scheduled from this point to the PDUFA date, to potentially withdraw the application if you feel like this is not gonna get approved? Thank you.
I probably cannot comment to your satisfaction on those matters because obviously, this is still quite fluid as to what would be a potential path forward for omecamtiv mecarbil. What I can say is that the advisory committee interactions yesterday, illuminated certain issues amongst advisors, and what we need to understand is to what extent are those shared by FDA. You could well imagine that the briefing book that FDA published represents certain views amongst certain FDA officials. It's unclear yet how that may be perceived by others within FDA, and after the advisory committee, how might they view those matters as well. We've had very extensive interactions with FDA that were not encapsulated in the advisory committee meeting of yesterday. Therefore, there's a totality here that needs to be understood and now that starts the next chapter in these interactions.
I'm not gonna speculate on what might be the outcome of that, but you can appreciate that, there are various work streams that we'll be pursuing, in order to understand how FDA will, see the advisory committee voting and also other things. With that said, you asked a question about withdrawal of the application, and that hasn't been something we have yet considered. Should we consider that? We'll consider all options here, as is in the interest of all of our stakeholders. To maybe round out my answer. What I'll say is, we have strategies as may be enabling of a path forward, but we're also gonna be prudent. We're not going to do imprudent things as would not be in the interest of this enterprise and this company's commitments, to aficamten and other things.
You'll hear more about that, I'm sure, as other questions are asked.
Super helpful. Thanks so much, Robert.
Thank you. One moment for our next question, please. Our next question will come from Dane Leone from Raymond James. Your line is open.
Morning, Dane.
Hi. Thank you. Can you hear me? Good morning.
Yes.
Great. If we put what happened yesterday, within just kind of the broader context here, obviously your team going into this review process, felt very confident in terms of the risk-benefit that omecamtiv brings for these patients with HFpEF. That was obviously supported by your advisors, and the investigators that you've worked with on the clinical studies. The briefing docs obviously had a different opinion and raised a number of concerns that were generally supported by the AdCom panel yesterday. What I think this brings up is, yes, there's mixed views across the clinical community, in terms of the forward path of this drug.
Maybe for the investment community, the question is more, yeah, there's probably some value this drug should be approved at the end of the day, but what is it gonna take to get there, i.e., you know, commitment to running a supplemental study, which seems to be probably the path forward based upon yesterday's outcome. Beyond that, the patient population could be, you know, restricted to maybe a more targeted patient population than would generally have been envisioned, I think, or hoped for, by your team. Really, you know, what I think everyone's trying to figure out here is, you know, there could be a path forward for this drug. You know, cardiovascular docs would probably like to have this as an option for their patients.
Is Cytokinetics really, the company that should bring this forward given some of the challenges? Would it be better served for your team to work with or, you know, offload that commercialization or final stages of regulatory development to a company that just has the infrastructure already in place, has been through this before, and would be probably an easier incremental cost than probably what it's gonna take for Cytokinetics to get it there? Thank you.
It took me a while to get to the question, but I get it, and I agree with everything you said. I think there's a lot to be learned still from what might be ongoing interactions with FDA. There is a cost and an opportunity cost for us to consider this at as maybe certain scenarios. You know, your question included a reference to an additional study. Would we do an additional study? That's not on the table right now. We have no such plans to do an additional study, and were that to be asked of us, we'd have to think about that very critically in light of our other priorities, which is aficamten. Whether the commercialization of omecamtiv mecarbil could be handled by us, that all depends.
As the advisory committee was getting comfortable with where they could see benefit risk, they were describing a population very similar to one that we were already positioned for. Lower ejection fraction in patients who were advanced heart failure, worsening heart failure, at risk of hospitalization. Whether that is ejection fraction at 30% or 25%, whether that's with or without AFib, you're still talking about an excess of many hundreds of thousands of patients, maybe even over 1 million patients in the United States, who could benefit from a drug like that for which there is no existing treatment, especially for patients who are intolerant to guideline-directed medical therapy. We need to recalibrate in light of this feedback if it means that FDA is going to be adherent to the vote of the advisors and what that may mean.
I wanna underscore that our strategy was always omecamtiv as was to be an on-ramp to aficamten. The commercial infrastructure that we would build for omecamtiv would be the same as that we would deploy for aficamten, and we would benefit from time and market and synergies in support of aficamten commercial launch. That strategy may now need to be revisited if omecamtiv will not be approved. It's premature to go there right now until such time as we understand where FDA is in connection with yesterday's AdCom.
Very helpful. Thank you very much, Robert.
Thank you.
Thank you. One moment for our next question, please. Our next question will come from Jason Butler from JMP Securities. Your line is open.
Hi. Thanks for taking the question. Hi, Robert. I'm gonna try and make this a 2-part question if I can. I know you're not giving an updated financial guidance here, but can you just give us an overview of what the current cash position does, covers in terms of aficamten development and commercial prep? Then as you look forward, how are you gonna prioritize investments in aficamten and additional indications versus any additional investment in omecamtiv or the early-stage pipeline? Thanks.
Good questions, and I'm gonna turn to Ching to elaborate, but I'll share with you that we had already contemplated this as a potential scenario. As you'll hear now from Ching, we end the year in a strong position, enabling of us to prioritize aficamten in our R&D spending, and he'll provide some more specifics.
Jason, hi, thanks for the question. Obviously, we still have two weeks before the end of the year, but I could tell you that I expect that we will end the year with more than $800 million cash on the balance sheet. That's not including potential funds we could be, that could be available to us from the various deals we've done with Royalty Pharma and others. In terms of spending, as Robert said earlier, we're not giving financial guidance today. We will do so in our Q4 earnings call. The one thing I could say is our spending has always been gated on FDA approval, and that remains unchanged even after what transpired yesterday. As we planned, the emphasis of the research and development spending will be on aficamten.
I could tell you that our projected 2020 spend, 2023 spend in development, more than 70% of that funding will be directed towards aficamten.
To speak further to that means conducting and completing the SEQUOIA-HCM study, and you'll hear updates soon enough on where we are there, which I think you'll find encouraging. More so our plans for a second Phase 3 study in OHCM, as well as a third Phase 3 study, this one in NHCM. You'll see data from the cohort in REDWOOD-HCM in NHCM that we believe very strongly supports moving as swiftly as possible into Phase 3 in NHCM next year. Those continue to be our priorities in development spending to the tune of what Ching just shared with you.
Great. Thanks for taking the question.
Thank you.
Thank you. One moment for our next question, please. Our next question will come from Justin Kim from Oppenheimer. Your line is open.
Good morning.
Hi. Good morning, Robert and the team, you know, thanks for the perspectives on the additional clinical studies, presumably around the ejection fraction subpopulations and sort of the willingness to conduct those or sort of views of whether it's prudent to or not.
Just wanted to maybe touch on the sort of assays and sort of PK-guided dosing and you know what's just wondering from the sort of company's perspective, whether investment and sort of validating those things would be sort of on the table and something that, you know, the company is willing to work with the agency on, you know, presumably if due to other matters are sort of addressed and, you know, the drug is sort of, you know, has a great chance to sort of get approved on the basis of need.
I'll ask Fady to speak to this, but understanding that the LC-MS/MS assay that you heard referenced to yesterday, we believe to already be validated as would be potentially deployed were omecamtiv mecarbil to be approved next year. The immunoassay that you also heard referenced to is something that would require additional development work, as you heard Fady speak to. That would potentially take upwards of a year in order to be able to meet the different regulatory standards that may be required were that to be deemed required and essential as could be a companion diagnostic. That's a very different threshold or bar. All of this were it to be invested is still quite modest in terms of incremental spending. I'll ask Fady if he wants to speak to any other matters there.
No, nothing really. I mean, I think the, as you heard yesterday, the gold standard methodology LC-MS is already validated in a way that's clinically robust. The immunoassay as well is something that we have made a lot of progress in terms of progressing with the partner there that had developed the assay. There's not a lot more investment per se. I mean, there may be a lot of paperwork involved, but not a lot of investment.
Okay. Understood. Thank you.
Thank you. One moment for our next question, please. Our next question will come from Joe Pantginis from H.C. Wainwright. Your line is open.
Joe.
Hey, good morning, everybody. I certainly share your disappointment. I definitely wanna echo Robert's earlier comments about the quality of the presentations and answers. Thank you for that. My question wanted to focus on, I guess, past discussions with the FDA. There was a bit of a, you could call it an opening of the kimono by the FDA, referencing your discussions, surrounding the filing and approach that we were generally not privy to in your discussions with the FDA. I guess I would ask it this way: Is there anything to share that gives a layer of hope of them being receptive to a negotiated label despite the panel outcome?
I mean, even if you were to, like, look forward and, you know, you alluded to in one of your answers that, you know, a negotiated label of the reduced ejection fraction and even the potential black box with, say, AFib or something along those lines. I guess any visibility on past discussions?
That's a good question. Obviously, the briefing book disclosed things that we had not shared previously but were consistent, hopefully, with what we had indicated were the topics of discussion and risks and issues that we anticipated to be discussed at the advisory committee. What you saw referenced were specific communications from FDA to the sponsor, and remembering the sponsor at that time, was Amgen. As we transition Phase 2 to Phase 3, what might the Phase 3 study need to demonstrate in order to be a standalone pivotal trial? What you heard us say in the scripted remarks yesterday was where we believe that COSMIC-HF, in accordance with FDA-published guidance, lends mechanistic support as would be confirmatory evidence for what was observed in GALACTIC-HF.
You heard, hopefully, at the end of the advisory committee meeting, Norman Stockbridge refer to that matter in a way that I interpreted to be perhaps enabling of further discussion than what might be what was concluded by advisors in connection with COSMIC-HF as a confirmatory study. That's all to still be determined whether there's a path forward in that regard as would be enabling of the strategy as was originally our intention, COSMIC-HF confirmatory of what we saw in GALACTIC-HF. I don't think there's anything else that was perhaps revealing in connection with the FDA disclosures other than maybe the P values. As you know, in an 8,000 patient study, a P value of 0.025 is persuasive and compelling. Is it standalone sufficient?
That's what I think FDA will need to determine now that they have the totality of the evidence. Fady, anything you wanna add to that?
No. I mean, I think the, you know, the FDA positions on these things sometimes don't line up perfectly with the advisory committee's positions on these things. It's, it's really up to them to think about how to navigate the advice they received, whether the advice they received is congruent with the sentiment in the heart failure community writ large, and you know, what's the best thing for patients and availability of potential medicine that might be used in a, in a very high unmet clinical need population. I think, you know, in our future discussions with them, we'll, see where things go and, and, be able to report back to you as we understand how, that progresses.
I hope it was obvious from the discussions yesterday that Cytokinetics has been responsive and accommodating of feedback, acknowledging what were the limitations in GALACTIC-HF, but also where the opportunities may be for patients, and how we've been flexible in our interactions with FDA with a want to see this science translate into a new medicine for patients. I think that's what shareholders should expect of us, but at the same time, understanding when it may be necessary to pivot if that's in fact required.
Got it. I appreciate the feedback and good luck with the next steps.
Thank you.
Thank you.
Thank you. One moment for our next question, please. Our next question will come from Charles Duncan from Cantor Fitzgerald. Your line is open.
Yes. Good morning, Robert and team. Thank you for taking our questions and a very, very well conducted outcome yesterday. Appreciate all the diligence. I had a two-part question, if you will, and that is regarding anything new or learned from reviewing the briefing document or the discussion yesterday that would suggest new analysis that you could provide to the agency in the near term, perhaps before the PDUFA date. Secondarily, in terms of a proposed REMS, are you contemplating that or anything that you could change that would perhaps, you know, I guess, reduce the risk that the AdCom had highlighted? Thank you.
Thank you, Charles. Good question. There were a couple of things that advisors requested of us yesterday that given the format of the meeting, it wasn't possible to provide that analysis back to those advisors. FDA has certainly access to all of the information, not all of which got aired yesterday at the Advisory Committee meeting. I'm not aware of any new analyses that would necessarily be prompted by yesterday's discussion, although I am aware that there may be other analyses we and FDA are discussing. With regard to REMS, interestingly, that was not something that came up in our interactions with FDA nor at the Advisory Committee meeting. I'm not sure there's any value to considering a REMS program in light of yesterday's feedback.
At the end of the day, we'll have to see what FDA is interested in, both as it relates to the overall application and also yesterday. Fady, anything you want to add to that?
N o, we, obviously, we had a lot of, we have a lot of analyses that we didn't get to with the advisory committee, but we've shared with FDA and have had those discussions. I think it's not so much a question of analyses, but really a question of deciding whether the data support an indication in a specific population where the drug has a meaningful clinical effect, which obviously we believe there is such a population. The question with us is whether that is persuasive to FDA.
I can tell you if I ended up in that situation with low ejection fraction, I'd like the option to have the drug. Appreciate you taking the questions from me.
Appreciate that, Charles. If you were to do a, just a search on omecamtiv in the Twitterverse today, I think you'd find that a lot of heart failure specialists and experts in clinical research would agree with you.
Thank you. One moment for our next question, please. Our next question will come from Serge Belanger from Needham. Your line is open.
Good morning.
Good morning, Robert. Just one quick question. Can you remind us of the royalty financing agreements that are linked to omecamtiv? Are there any contingencies around those agreements in the event there's no path to approval or you choose not to launch the product? Thanks.
I'll turn to Ching to elaborate, and we can only share that which is public. The net of this is there were certain tranches of capital that tied to omecamtiv. We were expecting, albeit combined with potential business development, that we would have access to line of credit to support a potential launch of omecamtiv mecarbil. Now we'll have to revisit that, as it relates to debt on our balance sheet. That will be something that we will not be pursuing, as would have been possible if we were to be launching omecamtiv. If we do end up launching omecamtiv mecarbil, we'll revisit that. Ching?
Serge, I think you might be referring to the royalty deal we did with Royalty Pharma back in 2017. There is no contingency associated with that transaction if we don't get approval for omecamtiv mecarbil.
We sold then a revenue interest in omecamtiv mecarbil for cash in 2017, that there's no call back on that cash or recourse or anything of that sort. We have 2 deals with Royalty Pharma, one in 2017, one in 2022, that pertain to omecamtiv mecarbil.
Great. Thanks for the details.
Thank you.
Thank you. One moment for our next question, please. Our next question will come from Madhu Kumar from Goldman Sachs. Your line is open.
Good morning.
Good morning. Hey, this is Robert Blum on for Madhu Kumar. Thanks for taking our question. We were just wondering what's the physician overlap between HCM and HFrEF docs. Can you speak a little bit into how that pre-commercial planning would transfer over to aficamten?
Good question. I'm gonna ask Andrew Kalos , our Chief Commercial Officer, to speak to that. The good news is, he's always in his planning, been thinking about a franchise strategy where there is high overlap. We will pivot, and he can speak to sort of the overlap as we see it for aficamten.
T hanks for the question. There is a large overlap between both sets of physicians, mostly around location. They are co-located. You know, heart cell centers and HCM centers are also located in the same areas. When we did our initial analysis, the overlap was over 80%. Where the overlap really matters at the end of the day is how you deploy sales reps. Our sales reps are always going to be deployed after approval for omecamtiv. In the scenario where omecamtiv wouldn't get approved, then we would flex and focus on aficamten alone. In the scenario where it does get approved independent of label, that's always been contemplated as well. Either way, we're gonna be able to deploy a field force with that overlap in mind.
I think as Robert said, everything we've built is for the franchise. We've been building capabilities, infrastructure, hiring people, and really it was around commercializing a product and launching a product with either one or both products in mind.
Thank you.
The vast majority of the investment spending that has occurred to this point is in enabling of infrastructure to support omecamtiv and aficamten. Were it to be that omecamtiv is not approved, it's not difficult to redeploy that same infrastructure in support of aficamten, as would otherwise already be our objective in 2023. Understanding that we need to be ready to go to market for aficamten, as soon as 2024, 2025. Kudos to Andrew and his team for putting in place that support network, that infrastructure, as is flexible and can pivot if that's what is necessary.
Thank you. One moment for our next question. Our next question will come from Yasmeen Rahimi from Piper Sandler. Your line is open.
Good morning, team. I'm really sorry that AdCom did not go as well as you hoped for. I know you worked really hard on this. I also appreciate you hosting this call for all of us analysts and being able to ask our questions. Really helpful. I guess the first question that I have is like, can you maybe help us understand, are there any examples of a cardiovascular product where the AdCom voted not in favor, but the drug still received approval? If you could just maybe share that example with us, that would be helpful. 2, like, what would you say is the probability after yesterday's AdCom that the FDA is likely to require an additional study or a large study? Appreciate you taking this two-part question.
Sure. I'll start by, as you may know, there was a study published, where FDA tended to not go in favor of AdCom votes in about 20% of cases, although generally speaking, that was where the AdCom was in favor and the FDA was not. However, in cardiorenal, there are several examples, including one I lived with, albeit many years ago, where an AdCom voted against and the FDA ended up going in favor of a medicine that I was involved with in the mid-1990s. Since then, there have been several other instances where FDA has taken a position different than was the case with an AdCom. One was with CV Therapeutics, one was with The Medicines Company, and there are others too.
I think there's ample evidence to suggest that Cardiorenal Advisory Committees and FDA are not always on the same page, given the complexities associated with cardiovascular medicine. You heard from one of the advisors yesterday about how, at least he, as an individual, felt about the deliberations relative to what might have been were this oncology. I think FDA will be called upon in this case to consider the totality of the evidence here in support of potential approval, albeit, with an advisory committee vote that was not speaking to, in totality, benefit over risk. I do think there are precedents. How relevant they are, is something I think you as analysts will have to determine. There are certainly precedents.
In the meantime, we will maintain our high integrity commitment to science and data, that we have and see where that takes us.
Thank you, Robert. Then just in terms of the probability of additional studies required, what would you estimate that based on yesterday interactions?
I really can't speculate on that. I'm sorry. I just don't know how FDA will view that matter.
Okay. Thank you, Robert.
Thank you.
Thank you.
One moment for our next question, please. Our next question will come from Ashwani Verma from UBS. Your line is open.
Hi, thanks for taking our question. Just quick, does the regulatory outcome here change your view on the risk/reward on clinical programs for the rest of your pipeline? Like, do you think there are some stretch goals on any of the programs that now you feel a little less excited about, given the learnings from this experience? Second, quickly on the enrollment for Phase 3 SEQUOIA study, when can we expect an update, and how is that progressing? Thanks.
I'll ask Fady to comment from his perspective on the first part of your question in terms of risk/reward. I'll say personally, I think we were pretty sober to the risks associated with an advisory committee, and what might be expected from a benefit risk standpoint for a new cardiovascular medicine. It's for that reason, knowing that GALACTIC-HF produced admittedly modest effect on the primary composite endpoint, that we took the position that we did, where we thought the effect was more amplified. I don't think, I learned or we learned anything new yesterday from the discussion that would read on how we approach others of our pipeline projects. Fady?
I mean, I think as you know, two late stage projects we have ongoing. One is a cardiac myosin inhibitor for HCM. We obviously have already mentioned our plans to focus on that, and this doesn't really change our approach to that development program. The other being reldesemtiv in ALS. You know, things that we have ongoing now in earlier development, so far the strategies I wouldn't say have been influenced to a substantial degree. Obviously, we'll take into account some of the thinking from our discussions around omecamtiv mecarbil program and apply them there, no major changes in strategy for those earlier programs.
You know, as it relates to SEQUOIA, as it relates to COURAGE-ALS, these are studies that are very well powered, to determine what we expect to see and the benefit risk there is already something that we think is very much in favor of active arm in connection with what we've seen in Phase 2. I don't think that changes based on anything we discussed yesterday.
Thank you. I am showing no further questions from our phone lines. I'd now like to turn the conference back over to Robert Blum, President and CEO, for any closing remarks.
Thank you, operator, thanks to everybody who joined us on the call today. Obviously, the vote yesterday was disappointing, we're in a business where we are accustomed to potential risks and setbacks, and we mitigate those, and we manage around them. We pivot, and we move forward. In connection with omecamtiv, we will do that. We had already planned for this scenario, as would be enabling of us to focus on aficamten with our R&D spending. That remains our interest to us and high conviction to us. We will explore what might be viable and a path forward for omecamtiv mecarbil, but we will not bet the company on omecamtiv mecarbil and never intended to. It's always been our plan to manage a portfolio as is in the interest of science, patients and shareholders, and that remains our conviction.
With that, I'll end the call. Thanks very much for your interest, and we'll look forward to keeping you abreast of progress.
Thank you. This concludes today's conference call. Thank you for your participation. You may now disconnect. Everyone, have a wonderful day.