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spk17: And welcome, ladies and gentlemen, to CytoKinetics' third quarter 2022 conference call. 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 will allow for up to two questions 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.
spk16: Good afternoon and thanks for joining us on the call today. Robert Blum, President and Chief Executive Officer, will begin with a brief overview of the quarter and recent developments. Fatih Malik, EVP of R&D, will provide updates related to Omicampton McCarville and Appycampton. Andrew Kalos, EVP and Chief Commercial Officer, will review commercialization planning activities for Omicampton McCarbell and our specialty cardiology franchise strategy related to Affy Campton. Stuart Kupfer, SVP and Chief Medical Officer, will provide an update on real deceptive. Robert Wong, VP and Chief Accounting Officer, will provide a financial overview of the past quarter. And Ching Jha, SVP and Chief Financial Officer, will discuss our financial outlook and corporate development. Then finally, Robert Blum will provide closing comments and review expected upcoming key milestones. 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, including our current report regarding our third quarter 2022 financial results, filed on Form 8-K today. We undertake no obligation to update any forward-looking statements after this call. And now, I will turn the call over to Robert.
spk13: Thank you, Diane, and thanks for joining us on the call today. We made good progress in the third quarter, and we approached the end of the year in a strong financial position, with important progress achieved across the company and for our programs. Most notably, during the quarter, we advanced planning for the potential launch of Omicamp and McCarville, subject to FDA approval, potentially next year. Over recent months, we continued productive engagement with FDA as it continues review of our NDA, And we expect the late cycle review to occur later in this quarter in advance of the advisory committee meeting. Engaging constructively with FDA represents a key priority. And as such, our teams have been very focused on preparations that will continue for the next several weeks as we ready for our participation in this important meeting. We also advanced regulatory preparations for Omicamp to McCarville outside of the United States. we remain on track to submit a marketing authorization application to the European Medicines Agency before the end of the year, which aligns with our go-to-Europe strategy. For Afikampton, we continued conduct of Sequoia HCM, we completed patient screening in cohort four of Redwood HCM, and we furthered our startup activities for the second phase three trial of Afikampton as monotherapy. a phase three trial for which we expect to activate sites by year end and with enrollment to begin next year. During the quarter, we also shared results from two analyses of the open label extension trial of Affy-Campden, which both add to our understanding of the potential benefit of longer-term treatment with Affy-Campden, and in particular support our rationale for advancing the program to elaborate on the potential for Affy-Campden as could be monotherapy. For rel-deceptive, we were pleased that the DMC, or Data Monitoring Committee, recommended that Courage ALS continue following their review of unblinded data from the trial. As you know, our commitment to this unrelenting disease is longstanding, and it remains of utmost importance to us to conduct rigorous clinical research to fully understand the potential efficacy and safety of rel-deceptive. Patient enrollment continues to encourage ALS as that trial progresses towards its second interim analysis expected next year. It's an exciting and also busy time for all of us at cytokinetics, but as you'll hear today, we are positioned well as we continue to transform and mature our company. We eagerly anticipate next month's advisory committee, our PDUFA date in February, and numerous other corporate milestones across our early stage and later stage pipeline, as you will now hear more. With that, I'll turn the call over to Fatih.
spk05: Thanks, Robert. As Robert mentioned, a top priority for us over the past few months has been preparing for our upcoming advisory committee meeting for Omicamp of McCarville. Our team has conducted mock panels with experts and rehearsed our presentations for potential questions that may be asked at the ADCOM. We also are developing supportive materials intended to address topics that may arise. As a reminder, we do not yet have the meeting agenda nor the specific questions that FDA plans to ask, but we believe the Advisory Committee will be asked to consider questions related to substantial evidence of benefit, benefit risk, and dosing. Although our diligent preparations and the dedication of our team, we believe that we will be well prepared for the advisory committee. Ahead of our late cycle review meeting with FTC anticipated later this quarter, we've continued discussions around dosing of omicamptomacarbol, its benefit-risk profile, and heart failure patients, its benefit-risk profile and heart failure patients at higher risk for death and heart failure events for which the benefit of adding omicamptomacarbol to standard of care appears larger. We have also discussed with FDA the potential use of a test to assess plasma concentrations of omicamptovacarbol to guide dosing. In GALACTIC-HF, we employed an assay to assess plasma concentrations of omicamptovacarbol to guide dose titration, and with FDA, we're discussing the potential implementation of a test into clinical practice where omicamptovacarbol may be approved. Turning now to Europe, as Robert mentioned, we recently participated in productive meetings with assigned rapporteurs in preparation for our expected MAA filing, which is planned to occur by the end of the year. More regulatory developments are also expected in other geographies, as we'll provide in further updates. Regarding Apicampton, we've also continued to make progress on its development program. Sequoia HCM is enrolling patients globally. and we now have approximately 70 sites up and running in the U.S., Europe, Israel, and China, a majority of which our team visited in person in recent weeks to facilitate activation and patient enrollment. We expect that most, if not all, clinical trial sites will be actively enrolling patients in this fourth quarter. The trial is currently on track to complete enrollment in the first half of 2023, which should enable availability of top-line results in the second half of next year. Turning to cohort four of Redwood HCM, we completed screening for patients with nonobstructive HCM, and patient entry into the study should be complete soon. We anticipate sharing results from cohort four in the first half of next year, which may set us up for advancement into a pivotal phase three clinical trial in nonobstructive HCM in the second half of 2023. Finally, We furthered preparations and study start-up activities for our second Phase III clinical trial of afecamtin and obstructive HCM. As a reminder, the goal of this additional trial is to evaluate the safety and efficacy of afecamtin as monotherapy compared to metoprolol, a common beta blocker used by people with symptomatic obstructive HCM. This trial should hopefully provide a better understanding of the potential use of afecamtin relative to current standard of care therapy. The protocol has been finalized, site preparations are underway, and we expect this trial to have sites ready to go by the end of 2022, with enrollment to start in early 2023. During the quarter, we announced data from two analyses of the open-label extension study of Apicampton. Before I recap these findings, I'd like to say a word about the name of this study. Until now, we refer to this study as Redwood HCM OLE, but we have recently renamed it to FOREST HCM, which stands for Five-Year Open-Label Research Evaluation of Sustained Treatment with Apicampton in HCM. The name FOREST HCM more accurately reflects the inclusion of patients not only from Redwood HCM, but also from Sequoia HCM and other future trials of apicampton as it will be open to all patients who complete treatment in all clinical trials of apicampin. No changes have been made to the protocol related to this name change for the trial. And now to the findings of these recently presented analyses. The first analysis, presented at the inaugural meeting of the Hypertrophic Cardiomyopathy Society, evaluated reduction or withdrawal of background therapy in patients treated with apicampin. In the 20 patients who completed treatment through week 12 and who were eligible for this analysis, 17 achieved successful background therapy reduction or withdrawal, which was defined as at least one dose reduction of one medication to less than 50% of the baseline dose. Ten patients completely discontinued at least one medication, and five withdrew from all standard of care therapies. Background therapy reduction or withdrawal was unsuccessful in three patients who reinstituted a beta blocker as a result of recurrence of symptoms or elevated left ventricular outflow tract gradients. In patients being treated with apicamtin who achieved successful reduction or withdrawal of background therapies, LVOT gradients, NYHA class, and biomarkers remained similar to those who remained on other background therapies. These data support the rationale for choosing to now investigate afecamtin as monotherapy to potentially further elaborate on the next-in-class profile of afecamtin. The second analysis, presented at the Heart Failure Society of America meeting, evaluated patients' self-reported health status and found that as early as week 12, patients treated with afecamtin experienced substantial and significant symptom improvements as measured by the change in KCCQ score, and suggesting that afikampton is associated not only with improvements in cardiac function, but also symptomatic burden and quality of life improvements. Cytokinetics' presence at medical conferences like HFSA and the HCM Society has grown stronger over the years and is now inclusive not only of our presentations and posters, but also our exhibit booths, a sponsored symposia, support for independent medical education, as well as other medical affairs activities. These conferences represent opportunities to connect with leading researchers and healthcare providers, showcase the rigor of our science and clinical trials, as well as support healthcare professional learning objectives. Our growing presence signifies just how integral these conferences are as we approach the potential approval and launch of Omicamps of McCarville supportive of our franchise strategy, and the potential future approval and launch of ApiCampden. Aligned with these activities, we continued to expand our headquarters and field-based medical affairs team and filled key roles in the medical director, medical science, and medical communications functions. During the quarter, we also initiated activities with a medical information vendor to begin planning for our medical contact center. With that, I'll turn the call over to Andrew to provide an update on our commercial readiness activities in support of our planned specialty cardiology franchise strategy.
spk11: Thanks, Maddie. Our commercial readiness activities in the third quarter continue to put us on a path to launch should Omicamp and McCarver be approved. The progress to readiness includes a focus to market access with emphasis to ongoing payer engagement as we continue to meet with top national commercial and Medicare payers. We have been meeting with key regional payers as well to discuss the value in clinical data supportive of Omicamp and McCarville. We have continued our participation at payer conferences as well as medical conferences with the support of our medical affairs and HEOR colleagues. To advance awareness of the role of diminished contractility in heart failure, we were pleased to officially launch a disease state education campaign called the Heart of Contractility. during the quarter. The campaign will build awareness in the HCP community for worsening heart failure and the residual burden these patients face, as well as educate professionals about the importance of cardiac contractility and how it may fit as a consideration in the pathogenesis of heart failure. The campaign currently includes a website, digital advertisement, signage at medical conferences, and more. Furthermore, We also advanced the strategic design and development of our patient support and services hub, an important element bringing patient centricity to the forefront of our commercial strategy for Omicamp and McCarville. Turning to distribution and supply of Omicamp and McCarville, we have finished our third-party logistics agreement, advanced several wholesaler agreements, and have successfully completed strategic sourcing assessment of drug substance and drug product contract manufacturing organizations. As in previous quarters, our team continued to grow. We began hiring our final wave of Salesforce leaders with nearly 90% in place against our goal to have all of them on board by January. For our initial wave of sales leaders and those we began recruiting for recently, we have received a tremendous response with over 500 applications for just the first 12 positions with top tier candidates bringing exceptional experience, 14 years of cardiovascular experience, 13 years of leadership experience, and 22 years of pharma experience on average. I am confident that we're building a strong team and expect to fill our roles with similar high-caliber talent. At approval, if granted, we will begin hiring, onboarding, and training the sales reps. Specifically, within a week of approval, we plan to begin non-personal and digital promotion. At that time, sales leaders will be deployed in the field and medical affairs team will continue and engage with HCPs. We also expect to launch our product booth with related education at ACC next year. Beyond these activities, many additional elements to our launch strategy are moving forward behind the scenes in preparation for this potentially transformational milestone for our company. Finally, as it relates to advocacy during the quarter, we continue to develop our go-to-market strategy in the U.S. Under on-tribe, we hire a U.S. marketing lead and have initial plans in place by the end of the year. Building out our commercial readiness plan alongside launch planning for both Omicamp and McCarvel and Affy Campton may afford us key synergies and potential advantages and cross-training for all people involved. With that, I'll turn the call over to Stuart to provide an update on REL Deceptives.
spk04: Thanks, Andrew. During the third quarter, as relates to REL Deceptives, we proceeded with patient enrollment and Courage ALS. We now have more than 300 patients enrolled to date. Nearly all of the more than 80 sites are activated globally with robust enrollment in three main regions, the US, Europe, and Australia. Enrollment is progressing well, and we're on track to complete enrollment in the first half of 2023. Recently, we announced continuation of Courage ALS following the first interim analysis conducted by the Data Monitoring Committee which reviewed unblinded data from the trial. This interim analysis assessed for futility and was triggered 12 weeks after approximately one-third of the planned number of patients were randomized. A second interim analysis is expected to take place in the first half of 2023, which will also assess for futility, but will also allow for a fixed increase in total enrollment, if necessary, to augment the statistical power of the trial. At the same time, Courage ALS, Open Label Extension, or OLE, is now ongoing for patients who complete Courage ALS, and we are currently finalizing our plans to open a managed access program in the fourth quarter of this year. To remind you, this program will be available to patients who have completed any of our previous ALS trials, including Fortitude ALS, the Phase II trial of relative symptoms, and Vitality ALS, the phase three trial of tiraceptive. ALS patients are in great need of new therapies, despite advancements in progress in the treatment landscape, including the recent approval of the combination of sodium salbuterate and torursodial for patients with ALS. This approval is not only good news for patients, but reflects awareness and flexibility on the FDA's part to accelerate the pathway to approval. Patients with ALS are confronting an immense burden of disease, and we remain dedicated to the thorough evaluation of rel-deceptive for its potential in ALS. And with that, I'll turn it over to Robert Wong.
spk18: Thanks, Stuart. We ended the third quarter with approximately $896 million in cash and investment. Our revenue in Q3 2022 came primarily from ALS to co-fund Courage ALS. Our third quarter 2022 R&D expenses increased to $62.7 million from $48.4 million in the third quarter of 2021, primarily due to increases in spending for clinical development activities for Courage ALS and Sequoia HCM, and for our other cardiac muscle inhibitor and early research programs. Our third quarter 2022 G&A expenses were $48.2 million up from $26.2 million in Q3 2021 due primarily to higher outside service spending in anticipation of the potential commercial launch of Omicamp and McCarble and an increase in personnel-related costs, including stock-based compensation. During the quarter, we recognized a loss of $22.2 million related to the conversion and partial settlement of our 2026 convertible notes. And now Ching will review our financial outlook and corporate development strategy.
spk21: Thanks, Robert. We ended the third quarter in a strong financial position with approximately $896 million cash on the balance sheet, which includes the approximately $523 million in net proceeds raised from a 3.5% convertible senior notes offering. The notes have a 30% conversion premium and are due in 2027. In connection with this transaction, we repurchased approximately 117 million in aggregate principal amount of outstanding 2026 notes through privately negotiated transactions. In addition, We completed the unwinding of the cap call instrument we entered into in 2019 in connection with our 4% convertible senior note offering of that year. A transaction that we completed in October of this year and netted approximately $26 million of additional cash into cytokinetics. We are in a strong cash position despite our expectation that our burn rate may increase next year with the potential commercialization of Omicampium Carbo. In order to prudently manage our spend as we approach potential commercialization, we have gated a majority of launch-related expenses to post-PDUFA date. Furthermore, we have access to additional capital through our deal with Royalty Pharma subject to our fulfilling conditions to disbursement. We feel confident with our cash runway through employing our expense gating strategy, coupled with the option to draw down this capital as needed. And with that, I'll turn the call back over to Robert Ball.
spk13: Thank you, Ching. So as we proceed to close out 2022, a year of progress across our pipeline, we're entering what may be a new era for cytokinetics. Our company has matured. in terms of teams and capabilities, and with near-term potentially transformative milestones in our future, we are accelerating pace and progress to ready for what we hope will be an even brighter future. And as we look toward potential commercialization of our first medicine with another just a few years behind that, we remain steadfast to advance our earlier stage pipeline. Later this year, We plan to begin a phase one study of CK136, another novel cardiac muscle activator, with the goal of proceeding to potentially phase two studies in specialty cardiovascular indications that would be complementary to that for omicamptomacarbal. More to come on that exciting expansion of our pipeline soon. As to business development, we're continuing discussions with potential partners regarding the potential co-commercialization of Omicampton-McCarvel in Europe and Japan. In Japan, we're also aiming to pair rights for Omicampton-McCarvel and Affy-Campton together. Progress with regulatory authorities has informed these discussions. At the same time, we're clarifying our own deal interests, and we look forward to providing further updates. And finally, during the quarter, we celebrated the opening of our East Coast office located outside Philadelphia, where certain employees in our commercial, our medical affairs, and our supply chain teams will be based. The opening of this office further reflects on our maturation and optimism, and I'm pleased to see successes that we're achieving in hiring teams now on both coasts. With that, I'd like to recap our upcoming milestones. For Omicamp to McCarble, we expect to participate in an advisory committee meeting to review the NDA for Omicamp to McCarble on December 13, 2022. We also expect to launch Omicamp to McCarble in the U.S. pending potential FDA approval in Q1, 2023. And we expect to submit a marketing authorization application to the European Medicines Agency for omicamptobicarbol by the end of this year, 2022. For aficamptin, we expect to continue enrolling patients with obstructive HCM in sequoia HCM through the first half of 2023, with results expected in the second half of 2023. And we are expecting to complete enrollment of patients with nonobstructive HCM in the cohort four of redwood HCM with data expected in the first half of 2023, and we expect to begin a second Phase III clinical trial of afecamptin in obstructive HCM in Q4 2022. For CK136, we expect to begin a Phase I study in Q4 2022, and for rel-deceptive, we expect to proceed through the conduct of the second interim analysis for Courage ALS in the first half of 2023 and continue enrolling patients with ALS in Courage ALS with that expected to complete enrollment in the first half of 2023. And for our ongoing research, we expect to advance new muscle-directed compounds as well as conduct IND-enabling studies for one to two potential drug candidates. Operator, with that, we can now open up the call to questions, please.
spk17: Thank you. As a reminder, to ask a question, you will need to press star 11 on your telephone. Please stand by while we compile the Q&A roster. Our first question comes from the line of Akash Tiwari from Jefferies.
spk13: Hello, Akash.
spk15: Hi, Akash. Thanks so much for taking our questions. I have two, if I may. The first one is regarding the non-obstructive HCM trial. So, what's your internal bar of success for this study in terms of biomarker reduction? Do you need to show biomarker reduction similar to your OHCM trial? And also what data does Afikampton need to show to suggest that Afikampton is clearly differentiated from Mala in NHDM patients? My second question is about IRA. So given this now has become, it is approved, So given orphan disease drugs will become eligible for drug negotiation if the label gets extended. So will you reconsider your strategy here when you try to expand at the campus initiation for indications beyond just OHVM? Thank you.
spk13: So let's start with your second question and then the first, and I'll ask Fadi to comment on the first. With regard to the Inflation Reduction Act and its potential implications for AFI-CAMPTN, I do not foresee any implications that would alter our strategy with AFI-CAMPTN. We continue to be focused to the development of AFI-CAMPTN for obstructive and nonobstructive HCM, and we don't foresee that that new regulation will change our mind. We do believe, now to your first question, that we already have seen enough in Cohort 4 to give us confidence of a potential next-in-class profile for afikampton in nonobstructive HCM, we already believe we've seen enough in the open-label cohort to inform our want to proceed to end of Phase II interactions and the start of a Phase III study in 2023. As to particulars, I'll ask Fatih maybe to comment on what We consider it to be the bar here, but please understand we'll probably not be as specific in light of the fact that this is an open-label study. It is still underway and being conducted, and we don't want to do anything to jeopardize the presentation of those data when those data are final.
spk05: I'll just say, I think, you know, I won't, without giving any quantitative numbers, that what we wanted to see was consistency across the different domains that we investigated with Epicampton and NHCM. So that would be consistency of improvements in NYCHA class, in KCCQ, in biomarkers, in echocardiographic measures of response. And so, you know, I think it's not a specific number. But it's really consistency of effect across a range of domains, some of which would be part of the efficacy outcomes in a Phase III trial. And the second part of your question was, how would ApiCAMPT be differentiated in NHCM? I think there are all the same reasons that we believe it would be differentiated in OHCM, you know, applied in NHCM. And that has to do with rapid dose titration, lack of drug-drug interactions, reversibility of effect, and several other features that we've delineated previously. So I think those pharmacokinetic and pharmacodynamic properties apply to both OHCM and NHCM.
spk17: This is really helpful. Thank you. Thank you. One moment for our next question. Our next question comes from the line of Carter Gould from Barclays.
spk20: Hello, Carter. Hey, Robert. Thank you very much for taking the question. Good afternoon, you guys. I guess maybe to follow up on the prior question a bit, I'm sure you've seen Bristol's sort of phase three design in the non-obstructive segment there. in terms of, you know, the use of the dual endpoint here. Can you just talk for a second if that's sort of consistent with kind of how you're thinking about a potential phase three or any sort of lessons as you kind of review the design and maybe some of your interactions with KOLs and or FDA? And then on Omicamp, just quickly, any change in kind of how you're planning as you get a little bit closer to the adcom in terms of points of focus or key topics? Thank you.
spk13: Yes, so I'll start with your second question and then ask Fadi to comment on our views of the study as reported by BMS for Chem Zios. As it relates to the upcoming advisory committee, we have had several recent FDA interactions, and we're getting clarity on what we could expect to be those topics for discussion at the ADCOM, even as we have yet to still have the late cycle meeting and we don't have the formal agenda or formal topics. But for what has been a very regular dialogue with FDA now over many months, certain things are becoming more and more clear. And we specifically included some language in the press release regarding those matters. So you saw that we talked about in the press release that we expect there to be questions relating to benefit-risk, relating to dosing, and safety. So these are things that we continue to expect we'll be reading on what might be the label and how it would be ultimately drafted. It's possible that there'd be some other things. You know, we're not going to be able to go into specifics on this call for the fact that that wouldn't be appropriate, but I don't think there's going to be surprises in this for us, given what has been a very transparent and constructive dialogue we've been having with FDA. So you know that we are approaching this with the expectation that this is a positive phase three study. It's a pivotal study. It's a study that was discussed with FDA in great detail before it was conducted and after it was conducted. And while the overall effect was positive, we also recognize that the effect is larger when considering some of the pre-specified subgroups. So I think it's reasonable to expect that there's going to be some conversation about benefit-risk and where it may be observed and more pronounced. Ultimately, that's the appropriate thing for advisors to be, I think, commenting on. So I hope that's an answer to your question. Now, going back to your first question, I'll ask Fadi to comment on our views to the design of the BMS study and what it might mean for us.
spk05: Hi, Carter. I think, you know, the design of any of these studies needs to take into account finding endpoints that are meaningfully report on patient symptoms and function And, you know, similarly, I think as I've said on previous calls, all the endpoints that we examine in OHCM are applicable to NHCM, meaning NYCHE class, KCCQ, exercise performance. And so, you know, looking at the design of the Phase III trial with Mavik Hampton, I think many of those things are captured there, and you could expect any clinical trial design in this patient population to have those kinds of endpoints incorporated. So it's a little early for me to start providing specifics on our own thinking, and we'll plan to do that down the road. But in general, I think those sorts of endpoints that they're doing are clearly meaningful ones.
spk13: And maybe just to add, I don't think we were altogether surprised by what we're seeing. It's consistent with our expectations.
spk17: Thank you. One moment for our next question. Our next question comes from the line of Yasmin Rahimi from Piper Sandler.
spk13: Hello, Yasmin.
spk01: Hi, Robert and team. Thank you so much for taking my questions and congrats on the updates. Maybe the first question is, you know, we are looking forward to see the Mavicampt and Baylor data But maybe if you could just remind us if that population is captured in Sequoia, or would you have to run a similar study to being able to file or get accessibility to patients for reducing septal appellations? If you could just comment on that for us in terms of your plans. And then the second question is, you commented that screening has been complete in the non-obstructive HCM population. So, has your screen failure rates and non-obstructive differ from the obstructive population? If yes, what does that tell us about these two different populations? And thank you again for taking my questions.
spk13: Sure. So, just to clarify, you said looking forward to seeing the Valor data. We have seen those results, and perhaps what you meant was seeing whether FDA is going to be expanding the label
spk01: That's right, yeah.
spk13: Reflect the Valor data, okay. Yeah, because they did submit for the supplemental NDA. Yeah, that'll be interesting to see. As we have observed in the Valor data, it's, I'd say, revealing but perhaps not really advancing the ball beyond what we thought was already achieved in Explorer. And as you know, With Valor, they were able to demonstrate that patients who were eligible for SRT therapy upon receiving Mavicampton, several of them were no longer eligible for SRT, didn't meet the criteria any longer for that procedure in light of effects observed with the addition of Mavicampton. That's a positive. But there are very few patients and they were balanced between groups, very few events of SRT. And as such, we think a large portion of what was already known about Mavicampton was reaffirmed, if you will, in Valor. As far as your question specifically about our approach, I'll ask Fadi to comment, and then you also asked about the screen failure rate in cohort four. So, Fatih, if you wouldn't mind addressing those comments.
spk05: Sure. Hi, Yasmeen. You know, we do have a strategy for how patients in Sequoia might contribute to labeling for reduction of eligibility for SRT. I won't really go into further details about that, but I'll just remind you that patients eligible for septal reduction therapy are those patients with class 3-4 symptoms that have a high outflow tract gradients as are required to get into Sequoia in the first place. So I think we have a population that you might consider SRT eligible and as may inform eventual labeling for that particular aspect of therapy. Your other question with regards to cohort for screen failures. You know, we haven't seen screen failure rates to be any meaningfully different, I would say, than what we see, a little bit higher than the OHCM patients, in part because one of the parameters to get into these trials is a blood test. It's an NT-proBNP, and people don't always have one of those on record when they are screened, and so The results of that blood test may or may not determine eligibility. But all in all, we've been pretty pleased with the activity in that trial and how patients have proceeded from screening to enrollment.
spk01: Thank you, Tim. And one last question that I hate to be that annoying analyst, but everyone would love to hear your thoughts on how you're thinking about partnering Avicampton. Has your thoughts around that changed as we're approaching the end of the year and increasing enrollment updates? Just some commentary would be helpful and jump back into the queue.
spk13: Sure, so I'll take that. Our thoughts have not changed. We continue to intend to keep Avicampton for our own account. Our goal is to be proceeding go-to-market for Affy Campton on our own in North America and Europe. And while we have partnered it in China, we continue to seek a partner in Japan. Otherwise, partnering of Affy Campton is not something that we're pursuing.
spk17: Thank you.
spk13: Thank you.
spk17: Thank you. One moment for our next question. Our next question comes from the line of Joe Pantagenis from HC Wainwright. Hello, Joe.
spk08: Hey, everybody. Good afternoon. So, Robert, my first question, with your new Philadelphia facility, I just want to make sure that you have them all still working and not glued to the World Series. So, with that said, wanted to ask about the dosing test that you're alluding to regarding omicamptive. Is this something, or can you clarify, is this something you would like to maybe try to put in the initial label as part of your end-cycle discussions, or is this something that could be worked into clinical practice later?
spk13: Very good question. As you know, an assay was deployed in galactic HF to be enabling of dose titration and with the goal of getting patients within a target plasmons and titration range, and that assay worked pretty well. It's our view that it's useful, and therefore we're going to be doing what we can to make sure that an assay could be available upon the approval of omicamptomicarbol Whether that makes its way into the labeling or not is something that I think ultimately FDA will have to determine if the drug will be approved. That's the subject of dialogue that we've been having with FDA and we'll be prepared for any scenario hopefully that comes our way. But we don't yet have real clarity on that matter yet.
spk08: Got it, got it. And then with regard to the ALS program and the open label extension that you were discussing, I know it's early days here for that, but what kind of visibility do you have with regard to patient identification for enrollment? And even example, are you getting any prior to your exemptive patients yet or potential to really get them as you said you could?
spk13: So I'm a little confused by the question. So we're blinded in the study. Courage ALS is a study The open label extension?
spk05: You know, Joe, there are two ways in which we provide relative symptoms. The open label extension, it's only for patients that complete COURAGE.
spk08: Oh, it was the managed access program. Managed access program. Yes, yes, sorry for the misnomer there. Yes, that's what I meant.
spk13: That makes more sense, though. Thank you for the clarification. So under the managed access program, We're seeing patients who have rolled out of prior studies, and we will be making the managed access program available to patients, even some of whom have been on tiraceptive for five years. We have patients who have been on tiraceptive for five-plus years, even though we discontinued further development of tiraceptive back in 2017. And those are patients who are expressing interest in rolling over into the managed access program for REL dissentive. So that will be an option available to them later this year.
spk08: Got it. Very helpful. Thanks a lot, guys. Thank you.
spk17: Thank you. One moment for our next question. Our next question comes from the line of Jason Butler from JMP Securities.
spk19: Hi, Robert. Thanks for taking the questions. Appreciate the updated details on the commercial prep for Omicantib. Can you maybe just speak to some of the items that will be gated post-approval? And maybe if you could just give us your updated thoughts on reimbursement and the conversations you've already had and how you think about the reimbursement landscape for the drug. Thanks.
spk13: Thank you for asking. I'm going to ask Andrew Calos to be specific, but as you've already heard us say, and I'll just repeat, more than a majority, about two-thirds of the costs that we might expect would be associated with launch and post-launch are gated. And we're being very careful and prudent about what we invest in now, principally long lead time activities, as would be required to be in place in Q1 if this drug could be launched in the first half of next year. So that speaks to in-house, home office-based people who are going to be doing a lot of the planning work and some of the sales managers, not even all of them, as you'll hear from Andrew. And I'll ask Andrew to now elaborate.
spk11: Yes, sir, Jason. Thanks for the question. So in terms of gating, we're gating Things like our sales representatives, our patient support programs, media and advertising spend, meeting and events, speaker programs and speaker honoraria, anything that would be really operational, if you will, once a product gets approved. And those expenses are the majority of expenses for Earl McCanted, as Robert alluded to. So we have plans in place to execute all of those things, but none of those will occur you know, if we get approved, that's when they would occur. In terms of reimbursement and reimbursement landscape, as you probably know, the hard side of the market is, has more Medicare than any other kind of channel from a payer point of view, followed by commercial, and those Medicare and commercial payers are really controlled by a handful of PBMs on both sides. Those PBMs represent health care plans, Blue Cross Blue Shield, and major health care plans and employer groups. We've been interacting with regional payers like Blue Cross Blue Shields, as well as national payers like, say, United or CBS ExpressGrip. So every major player in the health care payer landscape, we've reviewed cytokinetics. We have meetings plans to go through actual more detailed clinical reviews. We're planning submissions for reimbursement in Medicare with several plans as well. So we have a very robust plan for access. And the access team, the customer-facing access team, those that would call on these as customers, were one of our first hires well over a year ago. So they've been in the field as long as they're medical colleagues and interacting with these payers for quite some time now.
spk19: Great. Thanks for taking the question.
spk13: Thank you, Jason.
spk17: Thank you. One moment for our next question. Our next question comes from the line of Madhu Kumar from Goldman Sachs.
spk14: Hello, Madhu. Hey, this is Rob on for Madhu. Thanks for taking our question. I guess our question is really how are you thinking about the subpopulations of non-restrictive HCM and heart failure with partial injection fraction for AFI?
spk13: Sure. So how are we thinking about subgroups, those who might be more likely, presumably, to respond to a cardiac myosin inhibitor? Fadi, do you want to take that?
spk05: Sure. I mean, I think with regards to NHCM, there are, you know, it's more rare than the OHCM patients. You want to try to be as inclusive as possible rather than sort of further subdivide them. On the other hand, you also want an objective marker of their disease that indicates that they have a significant burden of pathophysiology based on the progression of their disease. So like many trials, we would want to have eligibility gated by something objective in terms of a potential biomarker that is reflective of filling pressures or overall cardiac function, and then also their exercise function or symptoms. So when you think about subdividing the population, I think less about specifically excluding different types of NHCM as opposed to ensuring we have symptomatic patients that have significant cardiac dysfunction. And then the second question in HFPEP, HFPEP's a much more heterogeneous population, covers everything from ejection fractions of 55% and higher, covers people with diabetes and obesity and other issues that may be leading to their symptoms. So I think there we would tend to be more selective in trying to identify features in HFPEP that define a subpopulation that is more like our NHVM patients. And so, again, without being too specific, that's how we would approach it.
spk14: Thank you. You're welcome.
spk17: Thank you. One moment for our next question. Our next question comes from the line of Jeff Hung from Morgan Stanley.
spk10: Thanks for taking my question. For Courage ALS, can you just remind us what the trigger is for the second interim analysis next year? And then I guess for the potential adjustments to the size of the study, can you just talk about what the powering assumptions are for Courage ALS in terms of also, you know, what would the considerations be for needing to adjust the study size? Appreciate any color you can provide. Thanks.
spk13: Yeah. So the trigger is based on enrollment. And when we get to approximately two-thirds of the intended enrollment. That's what triggers the second interim with those patients having gotten out to the same time point. With regard to the powering calculations and the potential for upsize, I'll ask Fatih to comment on that, please.
spk05: Yeah, we haven't shared really the specifics of the powering and how the second interim analysis is constructed. We do expect to publish a design paper that will have some of those details in it. But maybe in generalities, I think the second interim has two objectives. One is a futility analysis that would allow the trial to either continue or proceed depending on whether there is a chance of that trial having a positive effect. So the trial really had very little chance of succeeding at the interim analysis, you know, then that would be a reason to stop. In terms of increasing the sample size, there are scenarios where there seems to be a positive effect, but we may be underpowered to detect that effect with, you know, good statistical confidence. And so in that case, the DMC can recommend increasing the the number of patients in the trial to give us greater statistical power at the end of the trial. And that's also, you know, there's some predefined limits around that which will be more forthcoming with down the road.
spk13: So I think you'll get more of your answers when that design paper publishes, but for the time being, I think that's where we're comfortable making that disclosure.
spk10: Thank you.
spk13: Thank you, Jess.
spk17: Thank you. One moment for our next question. Our next question comes from the line of Ash Verma from UBS.
spk13: Good afternoon.
spk12: Hey, thanks, Robert. Thanks for taking our questions. I have two. One on Bristol's MYK224. I think you might have seen this update. They're moving this into obstructive HCM. Presumably, this has like a shorter half-life and no DDIs, so some of the same advantages that we have understood that afikamptin may have over chemdials. Obviously, the clinical data is going to be the ultimate deciding factor here, but how do you think about the profile differences between afikamptin and MYK224 as we know right now? And second question, just on amikamptiv, so if your label does get PK-guided dosing strategy, then how do you see that impacting the commercial opportunity, if at all?
spk13: So, why don't we ask Andrew to comment on your second question, how might the inclusion of the PK-guided dose titration assay affect the commercialization? And then, Fatty can comment on your first question.
spk11: Sure, thanks for the question Ash. So in terms of PK guided dosing, we were planning and expecting all along that PK guided dosing would be in the label as it was in our clinical studies. So it's not expected to have an impact the way we looked at it and forecast it. And when we talked to, you know, cardiologists and clinicians, the patients, kind of the worsening heart failure patient who could be eligible as an appropriate fit for this medication, gets blood tests on a regular basis, you know, things like kidney function, blood sugar, et cetera. So, and it's only for the titration, getting started and getting the right dose is our expectation. So, you know, those factors and the factor that, you know, these types of tests occur often, you know, we're not anticipating it to have an impact on our commercialization of the product.
spk05: And just, Ash, with regard to your question about MYK224, you know, I think I can't really comment because I haven't seen any data. I haven't seen any data from that compound. I really don't know anything about its properties per se. And I think it's premature for us to make any comments.
spk13: I will say that, you know, we were aware of the existence of this compound for quite a long time. myocardia used to refer to it also as a compound that might have some preferential properties. It looks to me like it's reaffirming of what could be a next-in-class profile of afecamptin, and there are other things that obviously distinguish afecamptin from mavicamptin, but until BMS might generate data with 224, it would be premature to comment.
spk12: Yeah, thank you.
spk13: Thank you.
spk17: Thank you. One moment for our next question. Our next question comes from the line of Solim Syed from Mizuho.
spk06: Great. Good afternoon. Hey, good afternoon. Thanks for taking the questions. I guess a couple from me, if I can. One on Omicamptive and one on aficamptin. So I know you won't give us a peak sales number, Robert, for OMICAMP. So perhaps I'll word the question a little bit differently. You guys provided a lot of context today on the spend. Thanks for that. I'm just curious or have a little bit of confusion. Is the gating on expense, is that associated more with approval? Is it binary around that or is it more associated with the actual demand of the product? And as a secondary question to that, Is it possible for you to framework how you're thinking about when omicamptive becomes cash flow positive? Is there a bracket you can give us in terms of years on when omicamptive becomes cash flow positive the way you see it? And then secondly, on aficamptin, just curious to get your read on the overall obstructive hypertrophic cardiomyopathy market. after the Bristol print. They obviously put up $5 million, which was significantly below consensus. I was curious how that changes your view of the peak total addressable market there, and specifically to Aftacamp and the revenue opportunity. Thank you.
spk13: Sure. So, firstly, with regard to Omicamp to McCarville, our choosing to gate spending is a function of us recognizing that we need to be prudent as it relates to investment in Omicamptive ahead of its approval. But upon approval, you could expect that we will be committed to what we believe could be a very effective commercial launch. In terms of whether we'll let other determinants guide the titration of spending, I think that's only natural that we'll look to market access and other things as we might be then up-titrating spending in accordance with that launch. But we intend, if the drug is approved, to go at it in a meaningful way, as you would expect for a drug that could generate the kinds of returns that you and other analysts have projected. So I'm not going to speak to what might be potential peak sales. You're right. But we do think that this is a product that under our commercialization in the United States can produce positive net cash flows for the company. And in terms of how quickly, I think as would be not unlike other new medicines in this category, it's not going to happen where we are producing a profitable product in the first year. But we do expect this product to perform well, very well, in light of the strategy that Andrew and others are laying out and building on the clinical evidence. And in terms of how soon, whether it's year two, year three, that kind of thing, it depends on pricing. It depends on market access. Market access will be... slower in some areas here because this is largely a Medicare population, and we have to make sure we get through those Medicare bids. That process takes time. But you should expect that we believe that this drug is more than just providing a foot in the door for Affycampton. It's a drug upon commercialization that we think can move the needle for the company and its shareholders. So probably that's as good as I'm going to be able to do for you today. With regard to Affy Campton, let me be very clear. We have not changed our expectations at all based on the print from BMS, even as I acknowledge sales reported in the most recent quarter came in below Wall Street consensus. I continue to have every confidence that BMS is doing the right things by the launch of Mavicampton and they've already in their own comments reflected on how in October a lot of patients were converting from free goods and otherwise the number of physicians trained through the REMS program and being available to be prescribers and how many are continuing to prescribe and how few, if any, are repeat prescribers and dropping off. These are all the kinds of things that BMS knows very well and is building a commercial ramp for Mavacampton as we expected them to do. And hence, unless Andrew wants to add any comments, I'll just end by saying we continue to believe very significantly in the upside for Mavicampton and also as relates to Aficampton that could have, we hope, we believe could be a next-in-class compound. Andrew, anything else you want to say about the launch of Mavicampton and what we're learning?
spk11: I mean, I think you covered it well. I think, you know, BMS referenced over 1,000 patients, of which only a third are commercial that Robert alluded to. But I think we know, based on claims data, there's you know, well over 190,000 patients who have already been diagnosed and probably three to four times that number are yet diagnosed. So it's a pretty big market that needs to be addressed, and it takes time to develop a market. So as Robert alluded to, I think, and then BMS said themselves, you know, we're very bullish on this market and the opportunity for more than one player.
spk06: Great. Super helpful. Thanks so much, guys.
spk17: Sure. Thank you. One moment for our next question. Our next question comes from the line of Justin Kim from Oppenheimer.
spk13: Hello, Justin.
spk03: Hi, Robert and team. Good afternoon, and thanks for taking the question. Just a quick one on eligibility criteria for the second Phase III study of afikantin head-to-head with metroprolol. You know, I'm curious whether treatment experience is going to be a criteria there. You know, just given the evidence of background withdrawal that was presented recently, I'm curious how you're thinking about sort of investigating this compound against a beta blocker and whether you envision maybe randomized withdrawal or... you know, just, you know, how to think about sort of washouts of apitensin or beta blocker, you know, during this investigation.
spk13: Yeah, so you'll get your answer very soon when this trial design posts on clinicaltrials.gov, but maybe, Fatty, if you wouldn't mind doing what you can to answer.
spk05: Yeah, Justin, I think it's a good question. You know, the trial wants to randomized patients to beta blocker as monotherapy versus ampicamptin as monotherapy, and there are a couple ways to achieve that. You either capture new patients that are not yet on therapy and you randomize them, or as you say, you potentially have to withdraw patients on existing therapy, at least for a short time, and then randomize them to one or two active therapies. You know, we'll be more explicit about how we're going about that, but most of these patients can, many of them anyway, I don't say most, but many of them can withdraw from their background mental therapy for a short period of time and tolerate that okay.
spk13: And that's what we're seeing, the open label extension, and it's what's prompted a lot of the investigator enthusiasm for us to do this study.
spk03: Okay, great, great. Maybe just a clarification. In terms of the end of the study, is it fair to expect a washout of afecantin in this study as well?
spk05: You know, at the end of the study, we generally do have a washout period, so look for a reversal of the treatment effect as another indicator of the strength of the treatment. you know, of the on-treatment effect, so I would expect that at the end of the study.
spk03: Great. Thank you. Thank you.
spk17: Thank you. One moment for our next question. Our next question comes from the line of Dane Leon from Raymond James.
spk13: Hello, Dane.
spk09: Hi. We're going almost 10 minutes past the Amgen call right now, so that's an achievement in and of itself. Quick one for me. If you guys have looked at the launch of BaristaQuad from Bayer and Merck as kind of, you know, something to learn lessons from as you get near to an approval with Oma Camptive, I guess, you know, what are some of the takeaways from, you know, your side of how to maybe approach a, you know, a new drug that would be in the mix with, you know, guideline-directed therapy and patients that would be maxed out on that therapy? And is there anything just, you know, to make it really simple for all of us who aren't very smart, you know, is there anything that's like kind of a red line on this adcom and labeling of Omicamp to where, You know, to my point on Verisiquat, getting market share, you just wouldn't think it's worth it to really go at, you know, at least alone in the U.S. or Europe. You know, something that would just be prohibitively restrictive of access. Thank you.
spk13: Yeah, so good questions. I'll tell you that I'm studying very carefully the launch of Verisiquat. And we have very regular meetings here where we're looking at data arising from that, and it is very telling and informative. And to your point, going up against pillars of standard of care are challenging. I'm not going to say anything to denigrate Verisiquat, but I do think that the profile of patients who would benefit from omicamptive when added to standard of care is very clear. And I do think that there are things that we can learn in terms of how to make that known through omnichannel marketing, through promotion. And the number of reps, how they're deployed and positioned to what centers, these are all things that we're learning, some of which would be similar to Verisig what other things we're going to do because It seems that we can, and maybe they chose not to. It is a launch that is benefiting from, I suspect, the expectation that there'll be more data forthcoming. They're conducting, as you may know, a phase four study. But the patient who might best benefit from omicamptive is a higher risk patient, regardless of how you might look at risk, whether that's by ejection fraction, whether that's by blood pressure, potassium, recent hospitalization, BNP, any way you might look at it, the more the risk, the more likely patients may benefit from omicamptib when added to standard of care. And that's very much to our benefit. I guess there are scenarios around which it's conceivable the labeling would come back where it would be so restrictive that it wouldn't be a launch that we'd want to pursue, but those are not probabilistic scenarios based on the conversations we're having. So we really don't have a line in the sand around which we would expect not to go forward if approved. I don't think any of those scenarios are real. They're really more in the abstract. Andrew, anything you want to add?
spk11: Yeah, on that, on the second one, I think the important element there too, is that we expect at the camps and the launch nuts, you know, a few years after on the campus and a big line item of expenses, field force, and it's the same field force. So that is an element of kind of cost sharing on the first item. I think it's really about, you know, four things. One is focusing on the right patient type and clearly positioning it and explaining that to physicians, uh, to that we're focused on cardiology and heartfelt treatment centers. I think we're deploying where we're going to be focused on that very clearly. Patient support services and access. So it's a difficult business, but a pretty simple formula. It's just hard to execute sometimes, and we're really focused on those four things.
spk13: Thank you. Thank you.
spk17: Thank you. One moment for our next question. Our next question comes from the line of Charles Duncan from Cantor Fitzgerald. Yeah, hi.
spk02: Yeah, Robert and team, congrats on the progress and good luck with the upcoming adcom. I had a question that was probably related to the last one, and that is regarding the puts and takes of pharmacoeconomic value for only captive. I guess I'm wondering when you think about the benefit benefit risk calculation, What do you think are the key, what is the key element that you think creates value for patients with only captive and the data thus far? And would you use the same element in Europe? Would that be valued in Europe as well?
spk13: Very good question. And yes, both in the U.S. and Europe, there's a compelling, a very persuasive pharmacoeconomic value that accrues when patients Omicamp and McCarvel is added to standard of care and the end result is reductions in events. Those events being primarily heart failure hospitalizations for a population where hospitalization is a significant burden and where heart failure hospitalizations is the number one reason for hospitalizations in the United States. So you're getting to, I think, the crux of where we do see value, and hence why we believe we're meeting with such enthusiasm on the part of payers, especially if this is a new medicine that will be positioned for higher risk heart failure patients. They need not think about this for all of their heart failure patients, but payers are looking for ways to keep people alive and out of the hospital And that's exactly where omicamptive seems to have its most pronounced effect in galactic, especially for those patients deemed at higher risk of hospitalization. So there's a strong, a very solid value story here that you've begun to see us tell through analyses and presentations, and soon those will be publications that will be informing potential use of omicamptomacarbals. So while very often in these types of forums we talk about the clinical safety and efficacy, I do believe there's a strong economic and value argument here as well, and that'll be a key pillar of our messaging position.
spk02: Very, very helpful. If I could just sneak one more in for relative I know it's been a very substantive call but just quickly on that second interim I think you mentioned it's triggered by enrollment but I believe it's triggered by two-thirds enrolled through and exposed through 12 weeks. Is 12 weeks enough really to gauge whether or not the drug might be having activity that could translate to efficacy and what are your thoughts there?
spk05: Hi, Charles. You know, I'll ask Stuart Kupfer to answer that question. And just to be clear, you're talking about the first interim or the second interim?
spk02: Well, I'm wondering about the second interim. I know what the first interim was, but is it similar?
spk05: Well, the first interim was a third of the patients through 12 weeks. I'll let Stuart get from there.
spk04: Hi, Charles. How are you? Thanks for the question. Just to be clear, the second interim analysis is triggered when at least a third of the patients have reached 24 weeks of treatment. And this is sort of a critical analysis because that actually approximates or is consistent with the primary endpoint for the trial, change from baseline to ALS, FRS, or 24 weeks So, the secondary renounce will be more aligned with expectations for the primary endpoint. The first interim was also an important inflection point because that corresponded with the duration of treatment in the phase two trial, fortitude ALS. So, that was, you know, an essential benchmark in terms of determining you know, for that utility analysis.
spk02: Got it. Now that makes sense to me. Thanks for taking the questions. Thank you.
spk17: Thank you. Thank you. One moment for our next question. Our next question comes from the line of Rohit Basin from Needham and Company.
spk07: Hi, Rohit. Good afternoon. This is Rohit on for search. Thanks for taking our questions. For OMA-CAMPTIV, in terms of the MAA filing for Europe, would you wait for the outcome of the adcom and the confirmation of the PDUFA date before submitting? And then a second question for APA-CAMPTIV, has the launch of MAVA-CAMPTIV impacted the awareness and interest in terms of investigator and patient recruitment for Sequoia HCM? Thanks.
spk13: Sure. So, with regard to your first question and the submission in Europe of an MAA for Omicamp to McCarville. We consider those decoupled. We're not really looking to the ADCOM as would be guiding our intended submission of an application in Europe. We've already had, as I mentioned before, enough dialogue with FDA that we kind of have a good sense of what the ADCOM will be all about. We don't know, of course, the votes, but we know enough about how Omicamp to McCarville will be discussed, that we are approaching our MAA already with some knowledge of how FDA is thinking. And obviously, we've had interactions with EMA and rapporteurs ourselves, so we kind of understand what's the temperature in Europe. So we'll proceed. There is obviously, once you have submitted and the filing is accepted, you have day 120 and other opportunities to dialogue with EMA, and it's conceivable that the ADCOM vote and what might be a PDUFA action would inform how we approach a day 120 event, but not the submission itself. Your second question related to awareness of Affy-Campden and Sequoia, is that right?
spk07: Yeah, how has the launch of Mavicamcin impacted the awareness and interest in terms of investigator and patient recruitment for Sequoia?
spk13: Sure. I'll ask Paddy to comment on that, please.
spk05: Yeah. So, I mean, I think the field in general is very excited about cardiac myosin inhibitors for the treatment of this disease. And the, you know, enrollment of Sequoia I don't think has been significantly impacted because It's an option that some patients may consider. It's a relatively good option, I think, given the accessibility to open label drug after they complete the clinical trial. But importantly, this trial is not just being conducted in the United States. It's being conducted in Europe. It's being conducted in China, Israel. And so at this point in time, I'm sure there's been some impact, but I don't think it has slowed the trial down tremendously.
spk13: Thank you. Thank you.
spk17: Thank you. I would now like to turn the conference back to Robert Blum, President and CEO, for closing remarks.
spk13: Sure. So, thank you, Operator. In light of how long this call has gone on, I'll be brief. I just want to thank all of our participants. on the teleconference today for your continued support and interest in what we're doing at cytokinetics. Obviously, a lot going on and big events, milestones coming up in the near term. Progress. Operator, with that, we can now conclude the call.
spk17: This concludes today's conference call. Thank you for participating. You may now disconnect.
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