Cytokinetics, Incorporated (CYTK) Earnings Call Transcript & Summary

Good morning, and welcome, ladies and gentlemen, to the Cytokinetics 2020 Annual Stockholders Meeting. At this time, I would like to inform you that this meeting is being recorded. [Operator Instructions] I will now turn the meeting over to Pat Gage, the Chairman of Cytokinetics Board of Directors. Please go ahead.

Welcome, ladies and gentlemen. My name is Pat Gage. I am the Chairman of Cytokinetics Board of Directors. It is a pleasure to welcome you to our 2020 Annual Meeting of Stockholders. The meeting is now called to order. I've asked Mark Schlossberg, our Senior Vice President, Legal, General Counsel and Corporate Secretary, to record the minutes. Before proceeding to the formal business, let me introduce Robert Blum, the company's President and Chief Executive Officer, who will provide an overview of the company and our plans for 2020 after our formal proceedings. In addition, members of the Cytokinetics Board of Directors, management and employees are also joining the call with us today. I would also like to introduce Richard Ramko of Ernst & Young, the company's independent registered public accounting firm, who is available to respond to appropriate questions. Now I would like to turn the meeting over to Mark Schlossberg to conduct the formal business of today's meeting as set forth in our notice of annual meeting and proxy statement. After the formal part of our meeting, we will review the company's recent business activities.

Thank you, Pat. I have at this meeting a complete list of the stockholders of record of the company's capital stock on March 23, 2020, the record date for this meeting. I have proof by affidavit that the notice of Annual Meeting of Stockholders was deposited in the United States Mail commencing on April 3, 2020, to all stockholders of record at the close of business on March 23, 2020. The affidavit, together with the notice, the proxy statement and the proxy will be filed with the minutes of the meeting. In addition, [ John Forescue ], Senior Director, Legal Counsel and Assistant Secretary, will serve as the inspector of elections to carry out the duties set forth under the General Corporation Laws of the State of Delaware. Mr. [ Forescue ] has signed his oath of office as inspector of election. The oath of inspector of election will be filed with the minutes of this meeting. The inspector of election has advised me that we have present, in person and by proxy, a sufficient number of shares to constitute a quorum. So the meeting is duly constituted. We will vote by proxy and written ballot today. If you are a stockholder attending the meeting today in person and have turned in a proxy and do not intend to change your vote, then it is not necessary that you vote because we will count your proxy. Those attending the stockholder meeting present in the room today, who did not turn in a proxy or who wish to change their vote and have your proxy card with you, please raise your hand. Are there any additional proxies to be submitted at this time? Is there anyone present, whether or not you've already submitted a proxy, who now want to vote in person? Okay. After you completed your ballot, please give it to the inspector of election, along with your voting control number and register your name with the inspector of election. The polls are now open for voting this May 13, 2020, at 10:34 p.m. The polls will be closed to voting after we go through the matters to be voted on. We will first present the 4 proposals submitted for approval. Please save all questions related to the proposals for after all the proposals have been presented, after which we will announce the preliminary results of the voting. Election of directors. The first item, proposal 1, is for the election of directors. The following 3 directors are nominated by the Board of Directors as its Class I directors of the company to serve until our 2023 Annual Meeting, L. Patrick Gage, Ph.D; Edward M. Kaye, M.D.; and Wendell Wierenga, Ph.D. The Class II and III directors recommend that the stockholders vote for the Class I nominees. The second item of business, proposal 2, is the approval and amendment of -- and restatement of the company's 2015 employee stock purchase plan to increase the number of authorized shares reserved for issuance under such plan by 500,000 shares. The Board of Directors recommend that shareholders -- excuse me, stockholders vote for the approval of this proposal. The third item of business, proposal 3 is ratification of the selection of the Audit Committee of our independent auditors. The Audit Committee of the Board of Directors has selected Ernst & Young LLP to serve as our independent registered accounting firm for the fiscal year ending December 31, 2020. The Board of Directors recommend that the stockholders vote for the ratification of this selection. The fourth and final item, proposal 4, is an advisory vote on the executive compensation of the company's named executive officers as described in the proxy statement. Stockholders have been asked to vote on an advisory basis on the following resolution: resolved that the company's stockholders approve on an advisory basis the compensation of the named executive officers as disclosed in the company's proxy statement for the 2020 Annual Meeting of Stockholders pursuant to the compensation disclosure rules of the SEC, including the compensation, discussion and analysis, the related compensation tables and the narrative disclosure to those tables in the proxy statement. The Board of Directors recommend that the stockholders vote for the advisory proposal. We will now review if there are any questions about the aforementioned proposals before we close the polls. If you have voted at today's meeting, will you please give your ballots to the inspector of election. It is now 10:37, and the polls for each matter to be voted at this meeting are now closed. No additional ballots or votes and no changes or revocation to ballots or proxies will be accepted. At this time, I would like to report on the results of the voting as tabulated by the inspector of election. Thank you, Mr. [ Forescue ]. Election of directors. L. Patrick Gage, there were 36,623,181 votes for. There were 5,073,157 votes withheld. There were 6,329,856 broker non-votes. For Edward MK, there were 41,525,258 votes for. There were 174,080 votes withheld and 6,329,856 with broker non-votes. For Wendell Wierenga, there were 41,335,624 votes for. There were 360,654 votes withheld. There were 6,329,856 broker non-votes. For proposal 2, the approval and amendment of the restated 2015 employee stock purchase plan. There were 41,482,926 votes for. There were 124,594 votes against. There were 110,818 votes abstaining. For proposal 3, ratification of appointment of Ernst & Young LLP as auditors. There were 47,692,900 votes for. There were 16,284 votes against. There were 317,008 votes abstaining. For proposal 4, approval of, on an advisory basis, the compensation of the company's named executive officers. There were 41,039,498 votes for. There were 481,460 votes against. And there's 174,380 votes abstaining. Regarding proposal 1, the proposal for election of L. Patrick Gage, Edward M. Kaye and Wendell Wierenga, Ph.D is carried. Regarding proposal 2, the amendment and restatement of 2015 ESPP, is approved. Regarding proposal 3, the appointment of Ernst & Young LLP as the company's independent registered accounting firm for the fiscal year ending December 31, 2020, has been ratified. Proposal #4, the resolution concerning the advisory vote on the compensation of the named executive officers, as disclosed in the company's proxy statement for the 2020 Annual Meeting of Stockholders, is approved. We expect to report our voting results on a current form, on Form 8-K, to be filed with the SEC within 4 business days after the end of this meeting. This concludes the formal business of the meeting. We would now like to begin our report to shareholders. The meeting is now concluded. The following discussion and presentation contain forward-looking statements under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Our actual results may differ materially from those projected in these statements. Factors that could cause our actual results to differ materially are contained in our SEC filing, including our most recent annual report on Form 10-K, quarterly report on Form 10-Q, current reports on Form 8-K. Copies of these documents may be obtained from the SEC or by visiting the Investor Relations section of our website. These forward-looking statements speak only as of today. You should not rely on them as representing our views in the future. And we undertake no obligation to update these statements. I will now turn the meeting over to Robert Blum, our President and Chief Executive Officer.

Thank you, Mark. In my role as President and CEO, I'm pleased to be addressing you at Cytokinetics' 15th Annual Stockholder Meeting. Thank you to everyone who has dialed into the call and here in person. We sincerely hope you and your families are safe and well. With 4 potential drug candidates advancing in clinical development and another poised to enter the clinic this year, we are well positioned to realize our Vision 2025, which foresees our being the leading muscle biology biopharmaceutical company that discovers, develops and commercializes new medicines that may meaningfully improve the lives of patients suffering from diseases of impaired muscle function and weakness. Six imperatives will enable our growth and transformation into a commercial organization over the next 5 years. These include: achieving at least 2 regulatory approvals for our pipeline drug candidates to enable commercial launches; building commercial capabilities; generating sustainable product revenues; doubling our development pipeline to 10 programs; expanding our discovery platform; and being that science-driven company people want to join. Our excellence in execution in 2019 laid the foundation for us to accomplish these goals. Under our collaboration with Amgen, we completed enrollment in GALACTIC-HF, the Phase III cardiovascular outcomes trial of omecamtiv mecarbil, our cardiac myosin activator in patients with heart failure, with more than 8,000 patients enrolled. GALACTIC-HF, the second-largest cardiovascular outcomes trial conducted, is designed to determine if omecamtiv mecarbil, when added to standard of care, can reduce the risk of cardiovascular death or heart failure events in patients with heart failure, high risk. The first interim analysis designed for potential futility was conducted in 2019 and the data monitoring committee, or DMC, recommended the trial continue with no changes to the protocol. Recently, the DMC conducted the second and final interim analysis, also testing for potential futility, but also for superior efficacy, and they recommended the trial continue. We expect top line results from GALACTIC-HF in the fourth quarter of this year. We're pleased to note that the FDA recently granted fast track designation to omecamtiv mecarbil for the treatment of chronic heart failure. Fast track designation may potentially expedite the review of a drug that is intended for the treatment of a serious or life-threatening disease or condition and demonstrates the potential to address an unmet need for such a disease or condition. Looking back on 2019, we also began METEORIC-HF, the second Phase III clinical trial of omecamtiv mecarbil, which is designed to evaluate the effect of treatment with omecamtiv mecarbil on exercise capacity in patients with heart failure. In response to the COVID-19 pandemic, Cytokinetics and Amgen have recently agreed to temporarily suspend enrollment in METEORIC-HF to protect the safety and health of clinical trial participants and health care professionals. Clinical site startup activities, however, are continuing to be prioritized with the objective to activate new sites throughout North America and Europe. We believe enrollment may be completed by the end of this year, Q4 2020, if enrollment can be reactivated by the end of Q2 2020. In 2019, Amgen also began a Phase I study of AMG 594, our cardiac troponin activator discovered under our joint research collaboration for the potential treatment of heart failure and other diseases in which a drug that increases cardiac performance may serve still unmet needs. The study is designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of AMG 594. Recently, in response to the COVID-19 pandemic, Amgen and Cytokinetics recently agreed to temporarily suspend enrollment in the Phase I study of AMG 594, again, to protect the safety and health of clinical trial participants and health care professionals. In 2019, we also unveiled a wholly owned independent cardiac myosin inhibitor program for the potential treatment of hypertrophic cardiomyopathies, or HCM, an inherited cardiovascular disorder in which the heart muscle becomes abnormally thick and obstructs blood flow out of the heart, resulting in chest pain, dizziness, shortness of breath, fainting during physical activity and even sudden death. There are no currently approved medical treatments that directly address the underlying hypercontractility of HCM. And in 2019, our drug candidate, CK-274, was the subject of Phase I data supportive of starting REDWOOD-HCM, a Phase II clinical trial in patients with obstructive HCM that began earlier this year. I'll provide further updates about that trial in a moment. Turning to our neuromuscular program. In 2019, results from FORTITUDE-ALS, our Phase II clinical trial of reldesemtiv, a fast skeletal troponin activator, or FSTA, for the potential treatment of amyotrophic lateral sclerosis or ALS, showed that patients on all dose groups of reldesemtiv declined less than counterpart patients on placebo or standard of care for measures of slow vital capacity, a measure of respiratory function and ALSFRS-R, a measure of disease progression with larger and clinically meaningful differences emerging over time. However, despite not meeting statistical significance for the primary efficacy endpoint of that trial, the FDA has granted orphan drug designation and the European Medicines Agency, or EMA, has granted orphan medicinal product designation to reldesemtiv for the treatment of ALS and spinal muscular atrophy. This year, we will engage with regulatory and reimbursement authorities to prepare for a potential registration program for reldesemtiv in patients with ALS. We recently [Audio Gap] Astellas, which provides Cytokinetics with the exclusive control and responsibility for the development and commercialization of reldesemtiv as well as CK-601 and other fast skeletal regulatory activator compounds. Our excellence in execution during 2019 has positioned us well for what could be a transformative year for Cytokinetics in 2020. In the corporate presentation that will follow, I plan to share a few more highlights of the progress we achieved in 2019 as well as point to some of our more recent activities in 2020 related to these development programs. You can find a PDF of the presentation slides under the Downloads tab in the webcast window. And with that introduction, I'll now begin my update on the company. I'll be referring to the slides that you can see on our website and on this webcast, and starting with the second slide, our forward-looking statements. I'll remind you that I am making forward-looking statements that are caveated with risk factors contained within our SEC filings. We don't undertake any obligation to update those forward-looking statements. And with that background, I'll begin. Slide #3 speaks to the mission of Cytokinetics. It hasn't changed. It remains to bring forward new medicines to improve the health span of people with devastating cardiovascular and neuromuscular diseases of impaired muscle function. Slide #4 speaks to the pipeline of our novel muscle-directed drug candidates. These have all emerged from the research conducted by Cytokinetics scientists under the supervision of Fady Malik, who's been with the company since its beginnings, and it's his vision we're executing on in connection with advancing this portfolio of novel mechanism drug candidates. We divide our pipeline into 2 verticals, those that are modulators of cardiac muscle, be they activators or inhibitors, or those that are activators of skeletal muscle. And as you can see on this slide, we have omecamtiv mecarbil, an activator of cardiac myosin, as our most advanced drug candidate in Phase III clinical trials. And as mentioned, we expect readout of results from GALACTIC-HF in Q4 this year. This program is being conducted under collaboration with Amgen since 2006. Also, you can see on this pipeline, CK-274. CK-274 is the subject of an ongoing Phase II clinical trial program comprised of a study called REDWOOD-HCM. I'll speak to that in a moment. But also, we're very pleased to announce that recently, we filed an IND, and it has been cleared by FDA for the advancement of CK-271, a second cardiac myosin inhibitor ready and poised to enter Phase I, hopefully very soon. And also, you see on this slide, AMG 594, a cardiac troponin activator, as mentioned, discovered jointly with Amgen, in Phase I, and I'll have more to say about that momentarily. So with our cardiac muscle vertical, you can see 4 drug candidates that represent innovations for directly activating or inhibiting the biomechanics of cardiac muscle function. Turning now to our skeletal muscle vertical. Reldesemtiv, our fast skeletal troponin activator, is the subject of Phase II clinical development that we believe supports progression to Phase III, albeit as will be further informed by ongoing activities. I'll have more to say about some of the Phase II study data in a moment. But also CK-601, another fast skeletal troponin activator, currently in IND-enabling studies, is advancing towards potential clinical trials. And in partnership with Astellas, since 2013, we have ongoing research directed to other activators of skeletal muscle performance. Turning to the next slide. This introduces the next several slides directed to cardiac muscle. Here you see on the next slide, #6, a picture of the cardiac sarcomere. This is the structure that forms the cornerstone of our drug discovery and innovation and the ingenuity of Cytokinetics scientists. We believe we were the first company to industrialize this structure for modern-day, high-throughput drug discovery, and we screened nearly 20 million compounds against this structure, initially somewhat agnostic as we bind compounds into classes of activators or inhibitors and again, specifically looking for compounds that can be highly specific and potent activators or inhibitors of these proteins specific to cardiac muscle. And from this research that began many years ago, we have advanced many different compounds in different chemical series that are activators of cardiac myosin or inhibitors of cardiac myosin or activators of cardiac troponin or activators of skeletal troponin in fast-twitch skeletal muscle. Turning to the next slide. This slide describes the pivotal Phase III clinical trial, GALACTIC. This is amongst the largest heart failure studies ever conducted. It completed enrollment with over 8,200 patients. Last year, 2019, it has been the subject of 2 recent interim analyses, one in 2019, one earlier in 2020, setting the table for us now, together with Amgen, moving towards, we believe, the completion of this trial for readout of results in Q4. This is a trial that's looking at omecamtiv mecarbil overlaid to standard of care compared to standard of care alone in patients who have been within one year admitted into hospitals with the diagnosis of acute heart failure. This study is being conducted in 35 countries and approximately 1,000 centers around the world. Turning to the next slide. This slide describes the baseline characteristics of patients enrolled in GALACTIC-HF. These data were recently presented at the American College of Cardiology meeting conducted virtually a few months ago. And as you can see in this slide, we recently presented data that underscores what the study was designed to demonstrate. The study design was published in a manuscript in February. And as you can see in this slide, we did indeed accomplish the objectives to enroll patients both within and outside the hospital, 25% of patients enrolled prior to hospital discharge. Yet the median time to index hospitalization is still rather proximal or short, around 3 months, indicative that these are patients at high risk of death or hospital readmission or other heart failure-related events. You can also see that the NT-proBNP median is in the range of about 1,900 to 2,000. This is a measure of cardiac wall stress and underscores that these patients are indeed at high-risk albeit within a range that we believe could still mean that they're salvageable with new medical intervention. You can also see that the left ventricular ejection fraction mean is about 27%. This is a measure of cardiac performance and cardiac output, and this underscores these are patients with impaired cardiac function, systolic or left ventricular dysfunction, but still within a range that we believe can be managed successfully with new treatment options. You can also see that patients in GALACTIC are receiving high standards of care adherent to guidelines. This was important and intended, and we believe that this augurs well for what could be the incorporation of omecamtiv into guidelines, if demonstrating superior to standard of care. With the next slide, Slide #9, you see how the GALACTIC demographics compared to recent results presented from other heart failure trials, and we believe GALACTIC, as designed jointly with Amgen and is operationalized by Amgen, is well positioned to deliver results that, if positive, which suggest that omecamtiv mecarbil does indeed represent a new treatment option to address still risk in patients despite new advances in the care of these patients and where there could be opportunity for omecamtiv mecarbil to become foundational to standard of care. So with that, I'll now turn to the next slide, METEORIC-HF. This is a second Phase III clinical trial that we began in 2019. This trial is being operationalized by Cytokinetics in collaboration with Amgen. And it's intended to look for the opportunity for omecamtiv mecarbil to demonstrate overlay to standard of care, increases in exercise capacity and time to exercise fatigue, as measured by cardiopulmonary exercise testing in patients with heart failure. We recently began the study, as I mentioned, in 2019, but more recently, together with Amgen, we decided it's in the interest of health care professionals and patients if we were to temporarily suspend enrollment in METEORIC in order to enable the care and well-being of patients and site personnel. We do expect, however, that if we can reactivate enrollment within the next few weeks, by mid-2020, we're in a position to complete enrollment in METEORIC by the end of the year or shortly thereafter. But certainly, it's important to note that the registration strategy for omecamtiv mecarbil does not pivot around METEORIC-HF. Instead, we and Amgen are committed that if the GALACTIC-HF results are positive, we would proceed to filing for regulatory approvals based on those results, even as METEORIC may not yet have read out, and we would expect METEORIC could, therefore, read out by midyear next year, perhaps in advance of when we might expect to commercialize omecamtiv mecarbil. Speaking to the commercialization opportunity, Slide #11. Omecamtiv mecarbil represents a new mechanism therapy for which in heart failure, there frankly have not been too many new treatments over the last several decades. However, one such drug was approved a few years ago, Novartis' Entresto, and it's depicted in terms of sales here. This is not meant to say that omecamtiv mecarbil and Entresto are the same, but rather instead to point to how Entresto commercial sales are doing, ramping-up quite nicely towards the objectives they've laid out for Entresto, that would be in the range of at least $2 billion to $3 billion, which I do believe they're on track to achieve in 2020, and potentially as high as $3 billion to $5 billion or $4 billion to $6 billion at peak sales. And they continue to demonstrate that with successes of Entresto in the commercial market that there is a still very high unmet need for new therapeutic options. I'll now turn to the next slide, which underscores that we and Amgen are already working closely together in commercial readiness activities associated with education and awareness in order to support the potential launch of omecamtiv mecarbil. We're also working together on objectives to enable our working together in a potential co-promotion arrangement with the goal of negotiating that co-promotion arrangement by the end of this year. The next slide speaks to our collaborations, one with Amgen and one with Royalty Pharma. We entered into our partnership with Amgen in 2006. They purchased an option at that time on omecamtiv mecarbil when it was then in Phase I. Under their sponsorship, we conducted additional Phase I studies and Phase IIa studies in order to inform their exercise of the option, which they did in 2009, enabling us to proceed together in joint development in furthering Phase II and other Phase III studies, which we have been doing, but at Amgen's expense. And we further expanded the collaboration in 2013 to include Japan. Together, we and Amgen have been advancing omecamtiv mecarbil under joint development programs and plans. And as we foresee the potential for commercialization, we would do that jointly as well under joint commercial plans, committees and activities. We exercised our option to co-fund and co-promote omecamtiv mecarbil, which will be done on a cost-reimbursement basis. And as we lean forward, we expect we're eligible for over $600 million in future milestone payments, approximately half of which are pre-commercial, and the other $300 million based on commercial sales as well as we earn royalties on increasing sales that start in the high teens and climb into the low 20s or approximate about 20% of sales. So we could foresee that if omecamtiv mecarbil is commercialized, this can be extremely productive and profitable for Cytokinetics, especially as we would be expecting to co-promote in North America, and with many of those costs reimbursed by our partner at Amgen. Back a few years ago, in 2017, we sold a piece of our royalty to Royalty Pharma. They paid us approximately $100 million in cash and equity for a 4.5% royalty stake in omecamtiv back then in 2017. That royalty remains an asset of Royalty Pharma, but the royalty I shared a moment ago, the net royalty still approximates about 20% of sales, even after what we would pay, Royalty Pharma. Turning now to the next program. Under our partnership with Amgen. AMG 594 is a cardiac troponin activator. As I mentioned, it's another compound discovered jointly that has the potential to increase cardiac performance but by a different mechanism, and we and Amgen are evaluating it in Phase I and considering how we might advance forward in Phase II, perhaps next year. AMG 594 is the subject of a Phase I study that we recently suspended temporarily in order to understand the impact of the COVID-19 pandemic. And we and Amgen will begin discussions if these shelter in place and other restrictions are lifted about how we might want to proceed with AMG 594. The next slide depicts the design of the Phase I study with nested single and multiple-ascending dose cohorts in healthy subjects. And again, we are temporarily suspended in this study. I'm now going to turn to programs in our cardiac vertical, but not partnered with Amgen, wholly owned and independent of that collaboration. Turning to Slide #16, you see CK-274. This is a next-in class cardiac myosin inhibitor that we're developing for the potential treatment of hypertrophic cardiomyopathy. It is a compound that follows behind another compound that we participated in jointly discovering with a company that spun out of our research called MyoKardia. That compound called mavacamten, was recently the subject of positive Phase III clinical trial results announced very recently, very encouraging data around, which we believe, it underscores the validation for this mechanism and this therapeutic hypothesis in treating these patients. We believe CK-274 has demonstrated advantages, which were designed into the molecule that render it potentially next-in-class and that may advance the field. This is [Audio Gap] meaning binary winners and losers. But rather instead, we think like many other cardiovascular categories, there's opportunities for CK-274 to advance the field given its properties. If you look at Slide #17, you see some of those properties demonstrated here from some of the Phase I data generated in 2019. You can see that CK-274 has very well-behaved pharmacokinetics and looks to be getting to steady-state exposure levels within approximately 2 weeks, thereby suggesting an ease of dose titration and more rapid opportunity to get to predictable, steady-state target doses. Furthermore, if you look on the next slide, #18, you see that CK-274 has demonstrated both in preclinical models and healthy volunteers a relatively flat PK/PD relationship, thereby suggesting that there's an opportunity for physicians to dose it confidently and safely without, perhaps, some concerns about overshooting or undershooting the doses relative to the desired pharmacodynamic effect. These are Phase I data to be sure, but we expect to be learning more about CK-274 in the Phase II trial, REDWOOD-HCM, on the next slide, #19. REDWOOD-HCM began earlier this year. You can see its design here. It's intended to assess CK-274 and its potential to affect left ventricular outflow tract gradient in patients with hypertrophic cardiomyopathy. This study began enrollment earlier this year and we're targeting over 20 sites in North America and Europe for what amounts to 18 patients per cohort. We expect this study to be at least a 2-cohort study with cohorts conducted sequentially. We did pause enrollment recently in cohort 1 for the reasons mentioned about COVID-19 and coronavirus. But in the meantime, we are proceeding with activating sites and other start-up activities with the objective to, hopefully soon, reinitiate enrollment in REDWOOD-HCM. We do believe that if we can do that by the end of the second quarter, we're in a good position, we believe, hopefully, to complete enrollment by the end of this year in cohort 1, and data from that cohort will be informing progression, we hope, to cohort 2. CK-274, the next slide, #20, is the subject of a development plan for which we foresee potential Phase III studies, not only in obstructive HCM, but also nonobstructive patients, and we'll have more to say about our plans with CK-274 as we roll forward. Suffice it to say that we're optimistic for this mechanism, and we believe there's potential for translation not only in hypertrophic cardiomyopathies but in other indications as well, including certain patients with heart failure and preserved ejection fraction. And it's with that in mind that we recently filed an IND and are advancing CK-271, perhaps into Phase I, soon, as well as other compounds in preclinical development. Again, the goal being to advance lead compounds, backups and follow-ons as is consistent with our leadership position in muscle biology. With that, I'll now turn to the next slide, which introduces our skeletal muscle programs. I'll move through these a bit more rapidly. Last year, we announced results from FORTITUDE-ALS, a Phase II clinical trial of reldesemtiv, evaluating it in patients with ALS who are receiving standard of care. This trial did not meet its primary efficacy endpoint with a P less than 0.05. But as you can see on Slide 22, there are encouraging data here that suggests a pharmacodynamic effect as measured at all doses relative to placebo or standard of care. And while these doses did not achieve statistical significance, I do think it's apparent that numerically, there does appear to be clinical activity here against an endpoint of respiratory function in a disease where patients die of respiratory failure. But however, perhaps even more encouraging on the next Slide, 23, our results from one of the secondary endpoints. And as you can see here, reldesemtiv appears to be having effect, albeit not statistically significant, but definitely of clinical magnitude in patients on their ALSFRS, a measure of respiratory function that's been validated as an approvable endpoint in the United States. We see these data as very encouraging and compelling, especially when considering that the effect appears large and consistent with other drugs that have been approved in this treatment setting. We also want to underscore that we're looking at these data in both prespecified and post hoc analyses to underscore if we can amplify that signal and enrich what would be the treatment effect by removing certain patients who may not have been progressing and, therefore, focusing to those who are declining with their disease. More to say about that later, but we are ongoing in regulatory interactions. We had, recently, a meeting with FDA face-to-face at their offices, and we received encouraging feedback for what may be a potential Phase III clinical trial of reldesemtiv in ALS. We're awaiting certain feedback from EMA, but we are readying for the potential start of reldesemtiv in a Phase III trial. But however, we've made clear that we will await the results of GALACTIC-HF before we make a commitment to start that trial and understanding our cost of capital before we may proceed. With that said, also, we recently completed negotiations with Astellas, around which they've committed to fund up to $12 million of what we expect could be approximately $30 million to $40 million for a trial we may choose to do for reldesemtiv in patients with ALS. That trial would be conducted over 2 to 3 years. So we're getting our arms around the regulatory issues as well as potential payer feedback and reimbursement opportunities as well as what would be the budget and time line before we might make a decision about proceeding with reldesemtiv. I'll now proceed to conclude this corporate update. Turning to Slide 24. I'll remind you of our Vision 2025. As we have entered 2020, this is foremost in our minds as we look to potentially proceed to commercialization of at least 2 of our drug candidates by the year 2025 and build what we believe to be a more sustainable commercial revenue base. At the same time, we're not losing sight of how we got here. We expect to be expanding our research platform. We expect to be doubling our development pipeline and all along the way, continuing to recruit and retain those employees who share our values and mission and be that employer of choice amongst patients and physicians working in this space. From our financing history, turning to the next slide, #26, you see that we have been a good exemplar of a company that's been able to rely both on dilutive equity capital but more importantly, on strategic partners capital in order to advance our business. We think that's a hallmark of the way we do business and our corporate development strategy, monetizing our innovation, leveraging partnerships and not relying entirely on shareholder dilution and equity capital to build our business. That continues to be the way we think about our business going forward. The next slide speaks to our end of Q1 financials recently announced on our Q1 earnings call. And as you can see here, we have over $235 million in cash and cash equivalents at the end of March 31, representing over 2 years of forward cash based on the financial guidance and net cash burn in 2020. And we think that's prudent in terms of how we think about continuing to manage precious cash, especially in these challenging times. I'll now point out our upcoming 2020 milestones. Foremost amongst these is the readout of results of GALACTIC-HF, which we expect in Q4 2020. Also this year, we hope to complete enrollment in METEORIC-HF, pending the ability to reactivate enrollment in that trial. Also this year, we expect to advance CK-274 in cohort 1 and hopefully complete enrollment and readout data from that cohort, again, if we can reactivate enrollment in that temporarily suspended study. And you also see the other milestones there depicted on that slide that speak to our continuing to manage across our portfolio. That speaks to the conclusion of this corporate update for 2020, and I thank you for your attention as I provided you feedback on both 2019 and prospects for 2020. I do believe that it's apparent that in providing this update on our progress, Cytokinetics is making true on the development of our innovative portfolio of first-in-class and next-in-class muscle biology-directed drug candidates. As mentioned, 2020 is a potentially transformative year for the company, a year in which we expect to present Phase III trial results from GALACTIC-HF, advance CK-274 in Phase II, and expand our cardiac myosin inhibitor clinical program as well as potentially progress reldesemtiv into a Phase III registration program, pending our review of GALACTIC results. Moreover, we expect to advance new compounds into development as well as expand our research platform. We remain committed to the patients, caregivers and shareholders who count on us to deliver continued progress against our goal of improving lives of people living with diseases of impaired muscle function. I want to thank all of those of you who participated in-person or on the phone in this stockholder meeting. And with that, the meeting will be adjourned.

Ladies and gentlemen, thank you for participating in today's conference. You may now disconnect.