Cytokinetics, Incorporated (NASDAQ:CYTK) Q4 2023 Earnings Call Transcript
Cytokinetics, Incorporated (NASDAQ:CYTK) Q4 2023 Earnings Call Transcript February 27, 2024
Cytokinetics, Incorporated misses on earnings expectations. Reported EPS is $-1.38 EPS, expectations were $-1.03. Cytokinetics, Incorporated isn’t one of the 30 most popular stocks among hedge funds at the end of the third quarter (see the details here).
Operator: Good afternoon. And welcome ladies and gentlemen to Cytokinetics Fourth Quarter 2023 Conference Call [Operator Instructions]. I will now turn the call over to Diane Weiser, Cytokinetics, Senior Vice President of Corporate Communication and Investor Relations. Please go ahead.
Diane Weiser: Good afternoon. And thanks for joining us on the call today. Robert Blum, President and Chief Executive Officer, will begin with an overview of the quarter and recent developments; Fady Malik, EVP of R&D, will provide updates related to aficamten focused to SEQUOIA-HCM and FOREST-HCM; Stuart Kupfer, SVP and Chief Medical Officer, will provide additional updates for aficamten relating to SEQUOIA-HCM and MAPLE-HCM, and will also discuss CK-586 and CK-136; Andrew Callos, EVP and Chief Commercial Officer, will discuss commercial readiness activities for aficamten; Robert Wong, VP and Chief Accounting Officer, will provide a financial overview of the past quarter; and finally, Robert Blum, will provide discuss our 2024 financial guidance and corporate development strategies before closing the call by reviewing expected key milestones for the year.
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 fourth quarter 2023 financial results filed on Form 8-K that was furnished to the SEC today. We undertake no obligation to update any forward-looking statements after this call. And now, I will turn the call over to Robert.
Robert Blum: Thank you, Diane. And thanks for joining us on the call today. The fourth quarter of 2023 represented a transformational inflection point for our company. As we turned the card on SEQUOIA-HCM, our Phase 3 clinical trial of aficamten for the potential treatment of patients with hypertrophic cardiomyopathy or HCM. The results exceeded our already high expectations and we began 2024 firing on all cylinders with renewed commitments to preparing for regulatory interactions and submissions with urgency, executing on the broad clinical development program following behind SEQUOIA-HCM, as well as activating the next phase of commercial readiness activities. On today's call, Fady will discuss our plans for presentation and publication of primary and other results of SEQUOIA-HCM, which will further elaborate on the efficacy and safety of our next in class cardiac myosin inhibitor.
And as well, we're how we're moving swiftly to regulatory submissions across the globe. And then Andrew will comment on how we're prudently planning for differentiated commercial positioning for our next in class opportunity. As important as SEQUOIA-HCM is to our path to commercialization, there's much more in our pipeline that we believe will meaningfully unlock shareholder value as the company continues to mature. Stuart will provide an update on the progress of MAPLE-HCM and the ACACIA-HCM, the additional Phase 3 clinical trials of aficamten, which will provide an on-ramp to potentially expanding the utility of cardiac myosin inhibitors as a first line treatment for obstructive HCM, as well as potentially provide a new treatment option for the growing number of patients with non-obstructive HCM.
As you will hear, there's been an increased enthusiasm and activity surrounding these trials on the heels of the positive results from SEQUOIA-HCM. However, much still remains ahead of us to bring aficamten to patients, but I'm confident in our ability to execute on our ambitious strategies. As you'll hear in more detail, we ended 2023 with a strong balance sheet thanks to reduced spending during the year. In the last quarter and earlier this year, we also added to our cash balance with an infusion of capital from our aftermarket or ATM equity vehicle. We're pleased to be reporting our financial guidance today with approximately two years of cash runway, when accounting for both our cash on hand and cash available to us and despite projecting an increase in our expected operating expenses in 2024.
Recently, we announced the retirement of Ching Jaw from his position as CFO in order to attend to his personal health. Ching's departure is unrelated to our business prospects and on mutually good terms with the company. On behalf of our senior leadership team, we support his decision for his well being and we express our gratitude for as many contributions to our company. Ching built a strong team that many of you may know, including Robert Wong, VP and Chief Accounting Officer, as well as Matt Yang, VP of Corporate Finance and FP&A. Together with the teams they have assembled, we're confident that Ching's departure will have minimal impact to day-to-day financial operations. Libby Schnieders, our SVP of Business Development, who has served our company for well over 20 years, continues to lead business development, so we do not foresee any impact on that front.
Furthermore, in anticipation of Ching having to attend to his health, in the fourth quarter of 2023, we brought on a seasoned consultant who previously served as CFO of a public biopharma company and who has extensive experience in financial planning and structured finance transactions. They will continue to work with me through this transition as we've already initiated a national search for Ching’s replacement, so we expect we’ll bring international commercial and capital allocation experience compatible with maturing operations. Cytokinetics is looking ahead to a bright future in 2024 and also beyond. And as we turn the page towards potential commercialization of the first medicine arising from our pioneering and leading muscle biology research with more to come as we continue to prosecute our R&D programs.
We're fortunate to be where we are today. But it is not by coincidence, it's a result of meticulous planning, risk mitigation, strategic foresight, perseverance and dedication. We're building a specialty cardiology company, leading with aficamten as the foundation and we have the pipeline, the passion and the people to make happen that vision as we believe we’ll further reward shareholders. With that, I'll turn the call over to Fady please.
Fady Malik: Thanks, Robert. During the quarter, we shared top line results from SEQUOIA-HCM, which as Robert said, exceeded our expectations. It was a truly extraordinary milestone reflective of an incredible commitment from so many, including our investigators, study staff, patients and of course, our teams at Cytokinetics. The results of SEQUOIA-HCM showed that treatment with aficamten significantly improved exercise capacity compared to placebo, increasing peak oxygen uptake or peak VO2, measured by cardiopulmonary exercise testing, by a least square mean difference of 1.74 milliliters per kilogram per minute with a p-value of 0.000002. The treatment effect with aficamten was consistent across all pre-specified subgroups, reflective of patient baseline characteristics and treatment strategies, including patients receiving or not receiving background beta blocker therapy.
Statistically significant and clinically meaningful improvements with a p-value of less than 0.0001 were observed across all 10 pre-specified secondary endpoints, including the Kansas City Cardiomyopathy Questionnaire clinical summary score at weeks 12 and 24, the proportion of patients with a greater than or equal to one class improvement in New York Heart Association functional class at weeks 12 and 24, the change in provoked left ventricular outflow track gradient and proportion of patients whose gradient fell below 30 millimeters of mercury at weeks 12 and 24, as well as exercise workload and guideline eligibility for septal reduction therapy. These positive results reflect rapid and sustained improvements of symptoms, functional capacity and heart failure status.
Aficamten was well tolerated with an adverse event profile comparable to placebo. Treatment emergent serious adverse events occurred in eight patients or 5.6% on aficamten and 13 patients or 9.3% on placebo. Core echocardiographic left ventricular ejection fraction or LVEF was observed to be less than 50% in five patients or 3.5% on aficamten compared to one patient or 0.7% on placebo. Importantly, there were no instances of worsening heart failure or treatment interruptions due to low LVEF. While these top line results provide a relatively comprehensive look at the overall effect of treatment with aficamten, we have an extensive plan to share the primary results and additional analyses in more detail in a series of published manuscripts and presentations.
We hope the first of these to occur at heart failure 2024, the annual meeting of the Heart Failure Association of the European Society of Cardiology, taking place in May in Lisbon. Along with the primary results from SEQUOIA-HCM, over the coming months, we plan to present and publish key data that may lend support to the differentiated profile of aficamten. One important analyses is to examine the clinical effectiveness of aficamten in patients across several endpoints in aggregate, examining the breadth of improvements patients experienced in SEQUOIA-HCM. In another, we plan to elaborate on the dosing and safety experience from SEQUOIA-HCM, which we believe informs the potential safety and monitoring needed in the clinical environment. In addition to these important analyses from SEQUOIA-HCM, we have a robust scientific communications plan over the coming year that includes manuscripts and congress presentations that will further elaborate on the effect of aficamten and other metrics of exercise capacity, cardiac remodeling from the CMR substudy, echocardiographic measures of systolic and diastolic function and cardiac structure, symptoms and quality of life and cardiac biomarkers.
We look forward to sharing these analyses with you in 2024 starting in Q2. I'd like to acknowledge the tremendous efforts by our steering committee and internal teams to support and execute on this ambitious plan of publications and presentations. Shifting over to FOREST-HCM, the Open Label Extension Clinical Trial of aficamten, we can report that over 90% of the patients eligible from REDWOOD-HCM and SEQUOIA-HCM have enrolled in FOREST-HCM, representing nearly 300 patients that will contribute to our understanding of the effects of long term treatment with aficamten. Please note that this does not include patients from the China cohort of SEQUOIA-HCM. These patients will eventually make their way into a China specific open label extension clinical trial.
In April, at the American College of Cardiology annual Scientific Sessions, we will present the efficacy and safety of aficamten in the first cohort of patients with symptomatic obstructive HCM that have completed one year of follow up in FOREST-HCM. Last month, we shared data at CMR 2024 from the cardiac magnetic resonance, or CMR substudy of FOREST-HCM. The results showed the treatment with aficamten for 48 weeks resulted in cardiac structural remodeling, improvements in cardiac function and stabilization of myocardial fibrosis, demonstrating that aficamten has potential disease modifying effects and ability to improve the architecture of the heart in patients with obstructive HCM. While this analysis is small, only 16 patients were eligible at the time of this data cut.
We plan to expand on these data in the future as more patients reached a one year mark and beyond. Regarding regulatory engagements, during the month of February, we held two meetings with FDA ahead of our expected submission of an NDA in the third quarter of this year. A first meeting to review the results of SEQUOIA-HCM and a second pre NDA meeting, providing an opportunity to align on the content and format of the NDA. We're pleased with the FDA's feedback, supporting the sufficiency of our proposed NDA submission package and the receptivity to a rolling submission plan. We believe that the positive readout for SEQUOIA-HCM, along with the favorable pharmacologic and DDI profile of aficamten continue to support the opportunity to achieve differentiated labeling and risk mitigation.
We look forward to providing future updates regarding our interactions with FDA this year. As to regulatory planning and interactions in Europe, we're similarly ready for submission of our marketing application in the fourth quarter of this year, and plan to meet with EMA in Q2 to inform preparations. Similarly, we're coordinating with our partners, JI XING in China to collaboratively support JI XING's plan to submit an NDA. Overall, our proactive planning in 2023 has enabled us to capitalize on the positive results from SEQUOIA-HCM and to proceed with urgency towards global regulatory submissions, as well as to consider expedited pathways consistent with our aggressive planning scenarios. Alongside all of this, from a medical affairs perspective, during the quarter, our therapeutic medical science liaisons continued profiling of HCM treatment programs, while our managed healthcare medical science liaisons began development of our payor clinical value proposition.
We also continued our support of medical education activities at medical conferences. As Robert said, the strength of the specialty cardiology company we are building is anchored in the power of our research engine and development pipeline with aficamten if approved, leading the way. The top line results from SEQUOIA-HCM have been well received by the HCM community of physicians and patient advocates who foresee that they represent what can be a meaningful advance in care. We're grateful for their support and we look forward to continuing to engage with them as we work to establish aficamten as a potential next in class treatment option for patients with HCM. I'll hand it over to Stuart to elaborate more on additional clinical trials progress we're making with aficamten and provide an update on our earlier stage clinical development pipeline.
Stuart Kupfer: Thank you, Fady. In addition to sharing positive results from SEQUOIA-HCM, during the fourth quarter, we continued enrollment and are building momentum with our two ongoing Phase 3 clinical trials of aficamten, MAPLE- HCM and ACACIA-HCM. We're pleased to see that screening and enrollment is accelerating and have been catalyzed by the announcement of results from SEQUOIA-HCM. In MAPLE- HCM, which is evaluating the potential superiority in aficamten as monotherapy compared to metoprolol as monotherapy in patients with obstructive HCM, nearly all US sites are now activated and we've now activated sites in the UK, France, Italy, the Netherlands and Israel. We expect to complete enrollment in MAPLE-HCM in the third quarter of this year, which would enable results from MAPLE-HCM to be available in 2025 concurrent with when we hope to be commercially launching in aficamten.
We believe that if MAPLE-HCM were to read out positively, it would provide support for the positioning of aficamten as a first line therapy for patients with obstructive HCM. For developing aficamten to capitalize on its next in class potential and MAPLE-HCM factors importantly into that strategy. ACACIA-HCM, the pivotal Phase 3 clinical trial of aficamten in patients with symptomatic non-obstructive HCM is currently focused on study startup. But we have the necessary IRB approvals in the US and the EU, we're progressing our clinical trial application through the new harmonized procedure. We plan to hold investigator meetings for North America, South America, and Europe in the second quarter, and look forward to continuing enrollment in this trial through 2024 with the objective to complete enrollment in 2025.
ACACIA-HCM represents an important opportunity for aficamten and tests a key therapeutic hypothesis for expanding the evidence to support cardiac myosin inhibition in a growing population of patients underserved by current treatment options. We believe that the results from SEQUOIA-HCM and REDWOOD-HCM faithfully add confidence to what we can expect from ACACIA-HCM, and our optimism is shared by clinical investigators. Both clinical trials have the potential to expand the utilization of aficamten and the HCM patient population and impact treatment guidelines. At the same time, we're pleased with the progress of our clinical trials of aficamten. In the past quarter, we also advanced our earlier stage development pipeline, notably with CK-586, our cardiac myosin inhibitor and development for the potential treatment of a subgroup of patients with heart failure with preserved ejection fraction or HFpEF.
Having completed analyses of a single ascending dose data, we proceeded to the multiple ascending dose portion of the study. We expect to complete the Phase 1 study in this quarter and subsequently share data in the second quarter of this year with plans to begin a Phase 2 clinical trial in the second half of the year. We believe that the positive Phase 2 data we generated for aficamten in patients with non-obstructive HCM support the development of CK-586 in a population of patients with HFpEF. This condition has many parallels to non-obstructive HCM. Currently in the United States, there are about 3.6 million people with HFpEF, which is expected to increase to 4.8 million by 2033. Approximately 30% to 40% of these patients present with characteristics that may make their condition amenable to cardiac myosin inhibition.
Even with SGLT-2 inhibitors, the first evidence based therapies demonstrating some benefit in those of HEpEF, there is still a high residual risk of cardiovascular events and a clear need for additional effective therapies. Additionally, during the past quarter for CK-136, our cardiac troponin activator, we continued analyses of the single and multiple ascending dose cohorts in the Phase 1 study with healthy participants and expect to complete the study in the second quarter of this year. In 2024, we plan to share more updates from our early stage pipeline and our research. As more programs mature from our labs into the clinic we will report on how in recent years we've extended our focus and muscle biology beyond muscle contractility to also include other programs entering development, representing potential innovations in muscle metabolism and energetics.
While aficamten represents the most important near term value driver for our company, our early stage pipeline and emerging programs from ongoing research demonstrate productivity against our vision 2025. The long term goal is to cement our leadership and muscle biology adjacent to exciting developments and treatments for cardiometabolic syndromes. We'll look forward to sharing more progress soon. With that, I'll turn the call over to Andrew.
Andrew Callos: Thanks, Stuart. During the quarter, ahead of our announcing the results for SEQUOIA-HCM, we continued commercial readiness activities for aficamten. Throughout 2023, our focus was on learning the first phase in our go-to-market approach. We commissioned multiple market research studies seeking insights from nearly 850 healthcare professionals and more than 160 patients with obstructive HCM, which revealed that the HCM patient journey can be complex and challenging. Furthermore, HCM can also negatively impact patient's overall mental health, social engagement, and other aspects of everyday life. We also tested a range of product profiles in market research prior to our receipt of the results from SEQUOIA-HCM. The tested attributes most closely resembling the actual SEQUOIA-HCM results revealed that healthcare professionals would perceive the results from SEQUOIA-HCM favorably and would drive use of aficamten if approved across a broad range of obstructive HCM patients.
These learnings are informing the strategic decisions we're making around the target product profile, positioning potential customer profiles in our patient services hub. Access, in particular, is a key focus for us aligned with our company values of keeping patients at the forefront of all we do, we're designing a comprehensive patient support program to facilitate and support patients in transitioning to treatment with aficamten inclusive of patient education resources and reimbursement support and affordability programs for eligible patients. In the fourth quarter of 2023, we held initial conversations with specialty pharmacies and patient and service hub providers to support our build of a differentiated patient services hub. Now that we have results from SEQUOIA-HCM this year, we are advancing to the second and third stage phases of our go to market strategy, design and build.
This year, we plan to build our patient support services, access strategy, inclusive of distribution model, contracting approach and pricing. Our seasoned account manager team is fully staffed and interacted with every major payor in 2023 to introduce Cytokinetics. This field-based payor account team will continue to further engage in 2024 to share the results from SEQUOIA-HCM and ensure payors understand the clinical meaningfulness of the results. In 2024, we also plan to finalize our product positioning and launch our market development and education campaign, while we develop our branded marketing campaign in support of a potential 2025 promotional launch. As we previously shared, we began building our commercial capabilities in the United States prior to the potential FDA approval and launch of omecamtiv mecarbil.
After receiving the CRL from the FDA, we maintained the infrastructure that had been built and further refined the team and activities to prepare for what now will be our first commercial launch with aficamten. Today, we have on board the majority of US based headquarter personnel that we expect to need, including marketing, field sales leadership, and individuals leading insight generation, market analysis, commercial strategy, systems and operations. We expect to expand the team in 2025 with HCP customer facing positions gated appropriately alongside the regulatory process for aficamten. In Europe, having hired key leadership positions last year, including our Head of Europe and Head of Market Access, we plan to only modestly expand our EU staff in 2024 while maintain a disciplined eye to spending and gating, [indiscernible] [costs of] regulatory submissions and feedback from health technology assessments or HTAs. It is encouraging to see favorable benefit assessment from HTAs in both Germany and France related to cardiac myosin inhibitors as a new treatment option for patients with obstructive HCM and we believe this bodes will the future reimbursement of aficamten if approved across major European markets.
Overall, I'm very pleased with the foundational commercial readiness work that we've completed ahead of sharing our results of SEQUOIA-HCM last year, which sets us up to nimbly advanced into the next phase of our planning in 2024 and can enable us to capitalize on what we believe will be differentiated positioning for aficamten in the treatment of patients with obstructive HCM. And with that, I'll turn the call over to Robert Wong.
Robert Wong: Thanks, Andrew. We ended the fourth quarter with $655.4 million in cash and investments, which included $162.9 million that we raised through after market equity vehicle in the quarter. Following the quarter close, we raised approximately $83 million net through yesterday with our ATM equity vehicle, which is not reflected in our year end balance. Our fourth quarter 2023 R&D expenses increased to $85 million from $75 million in the fourth quarter of 2022, primarily due to spending on our cardiac myosin inhibitor programs. Our fourth quarter 2023 G&A expenses were $44.1 million, down from $54 million in Q4 2022 due primarily to lower outside spending on commercial activities, offset by higher personnel related costs including stock-based compensation.
Overall, our net cash burn in 2023 was $414 million relative to what was our initial 2023 guidance of $420 million to $450 million. We believe we proved to be good stewards of shareholder capital by reducing spending ahead of the results of SEQUOIA-HCM at the end of the year, which puts us in a stronger financial position to begin 2024. Now, I'll hand it over to Robert Blum to review our financial outlook, 2024 guidance and corporate development strategies.
Robert Blum: Thank you, Robert. Today, we announced our financial guidance for 2024. The company anticipates revenue will be in the range of $3 million to $5 million, operating expenses will be in the range of $420 million to $450 million and net cash utilization will be approximately $390 million to $420 million. In terms of capital allocation, our priorities are focused on benefiting patients and enriching shareholder value anchored by a prudent spending plan that balances advancing our commercial strategy with investment in our pipeline. Our foremost priority is advancing regulatory submissions for aficamtem in obstructive HCM and ensuring commercial preparedness in key markets like the US and Europe. Secondly, in continuing MAPLE-HCM and ACACIA-HCM, we plan to maximize the therapeutic potential of aficamten.
And finally, we remain focused on growing our pipeline inclusive of CK-586 and bolstering our R&D platforms to sustain future innovation. Inclusive of the approximately $83 million net raised in recent weeks through our ATM as well as cash available to us under our loan agreement with Royalty Pharma, our current cash [balance] of 655 million at the end of last year represents approximately two years of forward cash runway based on our financial guidance and projected 2024 operating expenses and net cash utilization. With positive results from SEQUOIA-HCM in hand, we've been looking at the arc of capital requirements leading up to potential approvals and the global commercial launch of aficamten, as well as sustaining and growing R&D through profitability.
As such, we continue to focus on a multi-pronged approach to accessing capital that enables us to pull several different levers over time. As has been our history, we plan to monetize our R&D progress and preserve shareholder value via partnering, as well as structural finance engineering and other non-dilutive approaches. Our priority remains focused on business development. And you know, we've been focused on a Japan deal for aficamten. We’re in active discussions with multiple parties and I'm pleased with how that deal campaign is looking. Moreover, we're considering partnering CK-586 for the potential treatment of HFpEF, while also preserving key rights for Cytokinetics in both co-development and co-commercialization. We believe that our longstanding leadership in the area of cardiac myosin modulation for the treatment of severe cardiovascular diseases has enabled us to look at partnering in an advantaged way as would benefit shareholders while also preserving important shareholder value in major markets of value for aficamten.
And additionally, we may consider restructuring our debt and other novel ways to build on the momentum from SEQUOIA-HCM in structured finance transactions that we believe would augment shareholder value and importantly, would not subtract from it. I'll remind you that through our transaction with Royalty Pharma, we remain eligible for two additional loan tranches under our development funding agreement. The first tranche of $75 million became available upon our sharing positive results from SEQUOIA-HCM and we remain eligible to draw down for one year following our receipt of the results, which occurred in late December. The second tranche of $100 million will become available to us, were we to choose to draw on it subject to the satisfaction of certain conditions, most notable of which is the acceptance of an NDA submission for aficamten in the United States.
As we are now a company valued between $8 billion and $10 billion, we have an ambitious yet practical and realistic plan to increase shareholder value over the next three to five years, to that which would be upwards of $15 billion to $20 billion. How do we get there? By unlocking the value in our pipeline and maximizing our opportunities. It starts with aficamten in North America and Europe based on the results from SEQUOIA-HCM. From there, we hope to increase value as MAPLE-HCM and ACACIA-HCM readout results that now have higher probability of technical success. And next then, we expect CK-586 to advance through proof-of-concept and HFpEF with additional upside coming from our earlier stage pipeline. I also want to take a moment to address recent M&A speculation relating to Cytokinetics.
Since sharing the positive results from SEQUOIA-HCM, Cytokinetics has been rumored to be an acquisition target. While we will not and cannot comment on specific speculations, let me please be clear about one thing, we did not initiate nor do we have a sale process ongoing. However, as responsible fiduciaries to our shareholders, I can assure you that we thoroughly evaluate options that are presented. And as you heard me say a moment ago, we continue to advance business development discussions. We're optimistic about how those discussions are proceeding and we're committed to building a sustainable specialty cardiology company as starts with executing against our goal of bringing new medicines to patients. We take great care in fulfilling our duty to shareholders by ensuring that we're doing the right thing to deliver maximum value and controlling that which we can control.
We believe that can be best achieved by advancing our innovative science, ensuring operational efficiencies and thoughtfully and prudently managing and deploying capital to maximize shareholder value. We're beginning 2024 in an advantaged position. We have turned the page to the next chapter of the Cytokinetics story and the work we're now undertaking will set the stage for our first potential regulatory approvals we hope within the next 18 months. In the second half of this year, we expect to submit regulatory filings in both the United States and Europe for aficamten. You heard from Fady, in Q3, an MDA with FDA and in Q4 an MAA with EMA. We expect to be more precise as timing goes to our Q1 earnings call and especially as it relates on positioning and other aspects contained within the content of those submissions.
And we have ambitious goals beyond obstructive HCM, as well as beyond aficamten, including expanding our development pipeline with new compounds arising from our research extending beyond the contractility of muscle to the energetics growth and metabolism of muscle. Each of our programs in muscle biology has been designed to potentially address severely ill and underserved populations in need of new therapies. And our vision of building a specialty cardiology company is now being realized and we're well positioned for success. With that, I now would like to share our expected 2024 milestones. For aficamten, we expect to present primary results from SEQUOIA-HCM at a medical conference in Q2 2024. We expect to submit an NDA to the FDA in Q3 2024 and an MAA to the EMA in Q4 2024.
We expect to complete enrollment in MAPLE-HCM in Q3 2024. We expect to complete enrollment of ACACIA-HCM in 2025, but continue its enrollment in 2024. And we expect to continue advancing go-to-market strategies for aficamten. For omecamtiv mecarbil, we expect the CHMP to issue an opinion regarding the MAA in Q2 2024. For CK-586, we expect to share data from the Phase 1 study in Q2 2024. And finally for CK-136, we expect to complete the phase one study in the second quarter of this year. And operator, with that we can now open up the call please to questions.
Operator: [Operator Instructions] Our first question comes from Mayank Mamtani with B. Riley Securities.
Mayank Mamtani: So just quickly on the pre-NDA meeting that occurred, I was just curious how much of the FOREST-HCM data would be part of that submission? I believe by the ESC heart failure congress, you'd probably have about 150 patients to go through the titration phase. Just curious if how much of that is going to be important as part of the pre-NDA meeting and eventually make it into the NDA submission?
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