Good morning, welcome, ladies and gentlemen, to the Cytokinetics 2018 annual stockholders meeting. At this time, I would like to inform you that this meeting is being recorded and that all participants are in a listen-only mode. I will now turn the meeting over to Pat Gage, the Chairman of Cytokinetics' Board of Directors. Please go ahead.
Good morning, ladies and gentlemen. My name is Pat Gage. I am Chairman of Cytokinetics' Board of Directors, it is a pleasure to welcome you to our 2018 annual meeting of stockholders. The meeting is now called to order. I have asked Pete Roddy, our SVP, Chief Accounting Officer, and Assistant Corporate Secretary, to record the minutes. Before proceeding to the formal business, let me introduce members of the Cytokinetics Board who are with us today, as well as management. First of all, Robert Blum, of course, our CEO and President, he will be making remarks later, after the end of formal business. Our independent directors, John Henderson, Sandy Costa, Wendell Wierenga, Ed Kaye, Lynne Parshall, and Sandy Smith are also here. Joining from the company's management today are Ching W. Jaw, our Executive Vice President and Chief Financial Officer. Pete Roddy, who I introduced earlier.
Diane Weiser, Vice President of Corporate Communications and Investor Relations. Joanna Segal, Senior Corporate Communications and Investor Relations Specialist. Dave Cragg, Senior Vice President of Human Resources. Dr. Fady I. Malik, Executive Vice President of Research and Development, Dan Casper, Vice President of IT. In addition, let me introduce Rich Ramko, Partner from Ernst & Young, Mike Tenta, Outside Counsel for the company from Cooley LLP. I would like to turn the meeting over to Pete Roddy 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 this meeting, as I mentioned before, we will review the company's business activities and provide you with an opportunity to ask questions that you may have. Thank you.
Thank you, Pat. Good morning. I have proof by affidavit that notice of this meeting has been duly given and that the Notice of Annual Meeting of Stockholders, Proxy Statement, and Proxy were mailed on April 6, 2018, to all stockholders of record at the close of business on April 3. This affidavit, together with copies of the Notice, Proxy Statement, and Proxy, will be filed with the minutes of the meeting. In addition, the Inspector of Election, James Kirkland of Computershare, has signed his oath of office. The oath of the Inspector of Election will be filed as well with the minutes of this meeting. The Inspector of Election has advised me that we have present in person or by proxy, a sufficient number of shares to constitute a quorum, the meeting is duly constituted. We will vote by proxy and written ballot today.
If you have turned in a proxy and do not intend to change your vote, it is not necessary that you vote because we will count your proxy. Those of you who did not turn in a proxy or who wish to change your vote and have your proxy card with you should raise your hand. Are there any additional proxies to be submitted at this time? Is there anyone present, whether or not you had already submitted a proxy, who wants to now vote in person? The polls are now open for voting this May 16, 2018, at approximately 10:35 A.M. The polls will be closed to voting after we go through the matters to be voted upon. The first item of business is the nomination and election of directors.
The following three directors are nominated by the board of directors as Class II directors of the company to serve until our 2021 annual meeting. Robert I. Blum, Robert M. Califf, M.D., and Sanford D. Smith. The second item of business is the ratification 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 year ended December 31, 2018. The board of directors recommends that the stockholders ratify this appointment. The third and final item of business is the approval on an advisory basis of the compensation of the named executive officers as disclosed in the company's proxy statement for the 2018 annual meeting of stockholders. The board of directors recommends that the stockholders approve this proposal. This concludes the formal business of the meeting.
If you have voted today, there aren't any. Would you please pass your proxy cards in front to the aisle, et cetera. It's now approximately 10:40, the polls for each matter to be voted upon on this meeting are now closed. No additional ballots, proxies, or votes, and no changes or revocations will be accepted. At this time, I would like to report on the results of the voting as tabulated by the Inspector of Elections, James Kirkland. Thank you, Mr. Kirkland. There were present and in person 45,336,697 shares of common stock voted, representing 84% of the total shares eligible to be cast, constituting a majority. Regarding Proposal 1, the election of directors, each of Robert Blum, Dr. Robert Califf, and Sanford Smith have been elected as Class II director. Regarding Proposal 2, the ratification of Ernst & Young LLP as the company's independent registered accounting firm.
Ernst & Young has been ratified as the company's independent registered accounting firm for the year ending December 31, 2018. Regarding Proposal 3, the company stockholders have approved the compensation of the named executive officers as disclosed in the company's proxy statement for the 2018 annual meeting of stockholders. We expect to report our voting results on a current report on Form 8-K to be filed with the Securities and Exchange Commission within four business days after the end of this meeting. This concludes the formal business of the meeting, we would like to now begin our report to stockholders. Before we begin, the following discussion, including the Q&A, contains forward-looking statements under the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995. Our actual results might differ materially than those projected in these statements.
Factors that could cause our actual results to differ materially are contained in our SEC filings, including our most recent annual report on Form 10-K, quarterly report on Form 10-Q, and our 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 upon them as representing our views in the future, and we undertake no obligation to update those statements. I'll now turn the meeting over to Robert Blum, our President and CEO.
Thank you, Pete. In my role as President and CEO, I'm pleased to be addressing you at Cytokinetics' 13th annual stockholder meeting, and as we mark the 20th anniversary of our company operations. I'm happy to see that we have several of our stockholders here in person with us today, and I'd also like to welcome those of you who are dialed into this meeting. 2017 was a year that tested our resolve. In light of negative results from our first phase III clinical trial in people living with ALS, we rededicated ourselves to our fundamental mission and values and advanced and expanded our innovative pipeline of muscle biology-directed drug candidates. The power of our science and the benefits of a diversified pipeline strategy came into clear focus during the past year.
We now press forward with two first-in-class muscle activators in mid and late-stage clinical trials, as well as next-generation compounds proceeding in early development. With productive collaborations with Astellas and Amgen and a reinforced balance sheet, all of which provides a solid foundation on which we are planning for a prosperous future for Cytokinetics. In 2017, we suspended development of tirasemtiv, our first-generation skeletal muscle activator, following review of results from VITALITY-ALS, the phase III clinical trial, which evaluated its effects in patients with ALS. To be clear, we were profoundly disappointed that VITALITY-ALS did not deliver on either its primary or secondary endpoints. We also believe that data from VITALITY-ALS lend validation to the mechanism of action of fast skeletal troponin activation and that our next-generation skeletal muscle activator, reldesemtiv, formerly known as CK-2127107, may address certain limitations of tirasemtiv.
Reldesemtiv is the subject of a broad clinical trials program under our collaboration with Astellas. Cytokinetics is conducting neuromuscular trials, and Astellas is conducting non-neuromuscular trials. In 2017, we began FORTITUDE-ALS, a phase II clinical trial designed to assess effects on respiratory and other measures of muscle function after treatment with reldesemtiv in patients living with ALS. We also continued conduct of a phase II clinical trial to assess effects of reldesemtiv on multiple measures of muscle function in ambulatory and non-ambulatory patients with SMA. In 2017, Astellas also conducted clinical trials of reldesemtiv in patients with COPD, as well as in elderly adults with limited mobility. In both cases, to assess measures of physical function and exercise stamina.
We remain enthusiastic about the potential of reldesemtiv to increase muscle force, power, and time to muscle fatigue in rare diseases and conditions associated with aging, and we look forward to seeing results from these trials later this year. We also continue to conduct joint research activities with Astellas and expect to advance yet another skeletal muscle activator into development in 2018. GALACTIC-HF, the global phase III outcomes clinical trial of omecamtiv mecarbil, our cardiac muscle activator, continued to enroll patients in 2017 and is proceeding on schedule. This 8,000-patient clinical trial 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 high-risk heart failure. GALACTIC-HF is being conducted by Amgen in collaboration with Cytokinetics.
The first patient was dosed in Japan in 2017, that prompting a $10 million milestone payment from Amgen to Cytokinetics. Additionally, in 2017, we sold to Royalty Pharma a 4.5% royalty on potential worldwide sales of omecamtiv mecarbil in a $100 million transaction. You may recall that we had previously exercised our option to co-invest $40 million in the phase III development of omecamtiv mecarbil in exchange for an incremental royalty of up to 4% on increasing worldwide sales outside of Japan. As such, we gained the right to co-promote omecamtiv mecarbil in institutional care settings in North America with reimbursement by Amgen for certain of our sales force activities. Our 2017 deal with Royalty Pharma provided important non-dilutive capital to fund our continuing operations. With Amgen, we also continued joint research activities and recently advanced a next-generation cardiac muscle activator in development.
In the corporate presentation that will now follow, I plan to share highlights of the progress I just mentioned that we achieved in 2017, but more importantly, share some of our more recent activities related to these development programs and the outlook for 2018. Like the courageous people fighting devastated diseases of muscle dysfunction, like ALS, like SMA, and like heart failure, those who inspire us with their hope and optimism and who personify resilience every day, Cytokinetics demonstrated extraordinary resilience in 2017. We look forward to continued perseverance as we execute against our Vision 2020 this year and beyond. For those of you joining us by webcast, you can find a PDF of the presentation slides under the Downloads tab in the webcast window. With that review of 2017, I'll now begin my update on the company now for 2018. Afterwards, I'll open up for questions.
Again, I'll be making forward-looking statements. I refer you to our SEC filings for caveats to those statements, we do not undertake obligation to update those statements, instead refer you to those filings. This is a picture of patients we know, patients like Corey, patients like Ryan, patients like others who have come to our laboratories and who have inspired us and who have met with our scientists and other members of the team at Cytokinetics and told their stories, including a woman named Sarah, who joined us last week. Every day, we're motivated by people like those depicted in this slide. Their courage, their selflessness, and their inspiration guide us in our fight against these diseases of muscle dysfunction.
Here is a picture, slide five, of our late-stage pipeline of novel muscle biology-directed compounds, all of which were discovered by Cytokinetics scientists in our labs or those of our partners. We view that omecamtiv mecarbil is our most valuable program now in phase III. Omecamtiv mecarbil is the subject of a collaboration, as you know, with Amgen that dates back to 2006. As you'll hear in a minute, we are not only approaching the halfway mark in the 8,000-patient phase III GALACTIC study, but we're also soon to be initiating a second phase III trial. The first, GALACTIC, conducted and funded by Amgen. The second, a study that'll be underway, we expect, hopefully later this year, to be conducted by Cytokinetics, but also is funded by Amgen.
But this represents the leading edge of a vertical in cardiac muscle for which two other compounds have advanced recently from our research into IND-enabling studies. And in early development, we expect could move to phase I later this year. One is a next-generation cardiac sarcomere activator, also partnered with Amgen, jointly discovered under our research collaboration. This is a compound with a different mechanism of action than omecamtiv mecarbil. We have not yet communicated what is its mechanism of action. We expect we may be able to do that later this year at an R&D day we expect to be holding in New York, potentially in Q4. More to say about that later in the year. We're very excited about that compound as it represents a potential another vector for value creation under our leadership in cardiac muscle and the research and development that's ensued.
We also have another compound you see here depicted as cardiac sarcomere-directed compound. That compound also originated in our research. It is not partnered with Amgen, entirely separate and not subject to rights, responsibilities, and shared economics with Amgen. This is a compound that we expect could also be entering phase I later this year and represents for us not only an inflection point and value for increasing our investment in cardiac muscle, but also represents for us an opportunity for a further monetization like we've done historically so well at the company to potentially attract non-dilutive capital to advance another program forward, representing other upside in shareholder value. That's the left side of the company, the cardiac muscle vertical. On the right side of the company, another vertical in skeletal muscle.
Here, in light of the fact that we've suspended development of tirasemtiv, we think that reldesemtiv represents the next major value inflection point for shareholders. We're developing reldesemtiv, as I'll detail in a moment, in four indications, as you heard, two neuromuscular and two non-neuromuscular. The first of those studies is expected to read out in just a few weeks, that in patients with spinal muscular atrophy, the others later this year. And under our joint research with Astellas, we've identified yet another next-generation fast skeletal troponin activator, and that's also moving from research to early development and represents another potential bifurcation in value. You can imagine we might eventually develop one of these compounds for rare neuromuscular diseases, another for other indications that are more primary care in their nature. And all this is happening at Cytokinetics.
At the same time, our research engine continues to be very productive and high yield. You'll be hearing about other activities in our research, both with regard to Astellas but also in unpartnered areas over time. Cytokinetics fundamentally believes in investing in the promise of our leadership position in research. That's inherently important to our Vision 2020 five-year strategic roadmap, which we've discussed at these shareholder meetings in the past. We're getting closer to 2020, and we're also getting closer to realizing potential commercial value from first-in-class novel mechanism, muscle biology-directed drug candidates. All the while, we continue to maintain quality and integrity in our R&D activities and as we continue to advance these drug candidates together in line with what matters most to patients and regulatory authorities.
Over the long term, as we've discussed our longer-term strategy at shareholder meetings, our focus is on capitalizing on these two verticals, such that we're developing first-in-class small molecule compounds initially in severe diseases associated with muscle dysfunction, and over time, also extending that leadership position to syndromes associated with muscle weakness and aging, identifiable to what we hope to be our leadership position as a biopharmaceutical company, bringing novel products to an aging demographic focused to increasing health span. To do this and to do it well speaks to how we have and should continue to develop the corporation, not relying on dilutive financings, but rather a mix of financings, but also leveraging partnerships. Partnerships for access to capital, access to technologies, infrastructure, and geographic and other reach that goes beyond our current capabilities. We think we've done an unusually good job relative to peer group companies.
Over half of the capital invested in our programs to date have come from non-dilutive sources of strategic partners' capital. We think that's important on a go-forward basis as well. Even as we've already earned over $600 million in paid-in capital from strategic partners, we're still eligible for over $1 billion in milestone payments, half of which are pre-commercial, as well as royalties on sales and other expense reimbursement. We believe our highly productive R&D engine, coupled with our sophisticated approach to corporate development, has enabled us to establish this broad pipeline and also progress that in a prudently responsible way. With respect to omecamtiv mecarbil, here at this meeting in the past, we've underscored how this disease of heart failure with reduced ejection fraction is an epidemic. It's getting worse. It's getting worse because the cost of treating these patients is going up.
The number of these patients is rising. The morbidity and mortality associated with heart failure with systolic dysfunction continues to climb. The mortality risk here is higher than that of many cancers. As such, we need to do a better job with new medicines that can address impaired cardiac performance but do it safely. That's where I would argue we and Amgen are very well-positioned with omecamtiv mecarbil and the ongoing phase III program. Omecamtiv mecarbil, to remind you, was designed specifically to address liabilities of existing drugs used in the treatment of heart failure, many of which have been around for decades.
With omecamtiv mecarbil, we believe it has the potential to increase cardiac function and performance, reduce cardiac dimensions and volumes, do so in an oxygen and energy-sparing way without adversely affecting blood pressure, addressing the side of the equation, which right now is in urgent need of new medicines, despite introduction of medicines that address afterload in heart failure patients. You can see that our scientists, over 15 years ago, had a very thoughtful, comprehensive way of thinking about what might be the commercial need in heart failure down the road. So far, omecamtiv mecarbil, we believe, has delivered on all of these properties, which render it unlike any other drug in development for the treatment of this disease. As I mentioned, GALACTIC is approaching the 50% enrollment mark in the trial that is due to enroll a total of 8,000 patients.
Think about that for a minute. That means that over 4,000 patients have now received omecamtiv mecarbil between phase II and phase III studies. In phase III, we would expect about 2,000 patients have already received omecamtiv mecarbil in 35 countries and in approximately 900 centers around the world. Recently, the data monitoring committee of this study met and recommended to the sponsor that the trial continue, we believe that that underscores the promise and the potential safety for this mechanism as we now proceed towards completing of enrollment we expect in approximately one year. I'll remind you that that's a study that is driven by the accrual of events, as such, we expect we may approach the first interim analysis for what could be the potential of futility in 2019. We don't hope that we stop the study then, but rather the study would then continue.
The next interim analysis would then be potentially in 2020, again, gated by accrual of events, which could enable the study to stop early for overwhelming efficacy. If it goes to its full term, we'd expect that might be in 2021, that sufficient number of events are accrued to enable the breaking of the blind and the analysis of results. Along the way, we'll be conducting a second phase III study. Again, this one to be conducted by Cytokinetics as reimbursed by Amgen. This is a study designed to assess whether use of omecamtiv mecarbil in patients with heart failure may translate into extended time to exercise fatigue or increased exercise endurance or stamina.
We believe that if this study is successful alongside of GALACTIC and this drug is ultimately registered for marketing, that this trial could contribute to a differentiated positioning and a labeled statement for indication that we believe could confer significant advantage to omecamtiv relative to other drugs in the treatment of that disease and especially as would be deemed meaningful by payers. You know about our collaboration with Amgen. It continues now 11 years later, we expect that this will continue to be fruitful as we not only will be progressing omecamtiv through to the conclusion of phase III, also as we're moving a next-generation cardiac muscle activator into development as could extend the franchise and offer both life cycle management as well as other potential indications for this mechanism over time.
I already mentioned how in last year, we sold a piece of our royalty to Royalty Pharma in a relatively uncommon transaction, certainly for the fact that omecamtiv is still several years away from potential commercialization. It's unusual that a royalty fund would purchase a royalty. I think that underscores their enthusiasm for the mechanism and the potential commercial upside. Their having paid $100 million for 4.5% royalty plus a small equity stake, we believe sets for Cytokinetics as pertains to shareholder value, a new reference standard or benchmark, and by itself, that suggests that the company's current market cap undervalues our retained economics in omecamtiv alone, much less other programs advancing under our supervision. Important milestones for 2018. We expect the conclusion of enrollment in GALACTIC in approximately one year.
We expect to finalize preparations for a second phase III trial of omecamtiv mecarbil that could be underway by the end of the year or early in the next year. Turning to tirasemtiv. I'm not going to dwell on tirasemtiv because, as you know, we've suspended development, but I do believe there are certain lessons from the phase III trial that inform strategy with reldesemtiv. As you know, VITALITY-ALS was a second large international study we did with tirasemtiv. In each case, over 700 patients enrolled, and VITALITY was assessing the potential for tirasemtiv to alter the decline of slow vital capacity as measured at 24 weeks. We were looking at change from baseline at 24 weeks. Patients were randomized either to standard of care or one of three dose strategies for tirasemtiv.
Unfortunately, in this study, despite measures we took to try to address this potential risk, we saw that patients did not tolerate tirasemtiv as well as we would have wanted to see. About a third of the patients down-titrated and early terminated during the period in which we were evaluating the primary efficacy endpoint, such that that one-third of patients contributed in an intent-to-treat analysis to the final data, and for the most part, they were not on study drug. You can see on the left-hand panel that there was a modest but durable observable effect, not sufficient, we would argue, to warrant submitting at that time for registration, but enough to suggest there is a biologic activity for those patients who were randomized into the study. That includes all patients, including those who dropped out of the study early.
However, if you focus to those patients who remained in the study and who tolerated the drug, roughly two-thirds of the patients, their data on the right side suggests that there is a dose-dependent effect biologically consistent with the mechanistic hypothesis and sufficiently robust that we would say borderline statistically significant, at least validating the mechanism of action, if not the molecule. We believe this is telling, and in particular, for the fact that still approximately 100 patients who continued their treatment, completed the study, and insist on staying on this study drug in the open label extension suggest to us that for those patients who can tolerate the off-target lightheadedness, this is a drug that seems to be, at least as they would assess, conferring treatment benefit.
If you look at the AEs across the 48 weeks of double-blind treatment, you see that dizziness or lightheadedness accounted for the majority of the AEs, and we know that to be an off-target effect, a derivative of the fact that that compound crosses the blood-brain barrier and tickles a GABA receptor that mediates this lightheadedness. VITALITY-ALS did not meet its endpoints, but we do believe there's an evidence of effect that warrants further investigation of the mechanism of action as a viable therapeutic strategy in patients with ALS. Hence, to the credit of our scientists years ago, knowing that tirasemtiv had this liability with respect to blood-brain barrier, they designed and optimized reldesemtiv from entirely different chemical scaffold, a different chemical class, different intellectual property.
This compound, formerly known as CK-107, has been advancing as a backup, now in lead position relative to tirasemtiv, and it's the subject of our collaboration with Astellas. We studied it in five phase I studies. We know it to be more potent, have a higher free fraction in plasma; therefore, more is expected to penetrate muscle. We also believe it to be substantially more well-tolerated. In phase I, despite administering gram quantities of reldesemtiv, we did not identify a dose-limiting effect, and we know that it's been specifically designed so as to not cross the blood-brain barrier to the same extent. We and Astellas made a major commitment to the study of reldesemtiv, and in 2016 and 2017, we got underway studies that are described in these next slides. Two that we're doing at their expense and two that they're doing at their expense.
The SMA study we're doing and should read out very soon. In fact, we expect it to be data presented publicly on June 16 in Dallas at the Cure SMA conference. This is a study of a muscle-directed therapy in a disease where gene-directed therapies have made monumental advances for patients suffering from primarily type 1 disease, but increasingly also other types and older patients. We believe this approach could be quite complementary, mechanistically supplemental, and we think that this is a good study to test the hypothesis of fast skeletal troponin activation in adolescents and adults with type 2 and type 3 disease. This study has divided approximately 72 patients into two cohorts, a lower dose and a higher dose, half ambulatory, half non-ambulatory. It is a hypothesis-generating study. No single primary efficacy endpoint.
In fact, as you can see on this slide, number 27, we're looking at assessments across different measures of ambulatory, respiratory, and other functions in order to be able to understand how best potentially to design a phase III program. We're very interested to see these data very soon, and we'll make certain that they're communicated publicly promptly. However, this is one of four studies we're conducting with reldesemtiv, and the others I'll mention briefly. The ALS study is the one we might expect should have the highest probability of potential positive data, in large part because of the work we've already done with this mechanism in these types of patients. This is a large study, 445 patients enrolling now to either receive placebo or one of three doses of reldesemtiv, and we're measuring change from baseline in slow vital capacity at 12 weeks following randomization.
This is a study that's now enrolling in the U.S. and Canada, soon will be enrolling patients in other countries, we hope to see data from this study later this year. As I mentioned, Astellas is doing two studies on its own, one in patients with COPD, one in patients with frailty. We expect to see data from these two studies also later this year. In each case, we're assessing with reldesemtiv a different population, in both cases, looking at measures of exercise performance, stamina, and endurance. This could potentially open up a window on the use of this type of mechanism in patients who are seeking increased health span as they age. I won't go into this slide in any more detail. You've seen it in the past. Our relationship with Astellas initially entered into in 2013, expanded in 2014, expanded again in 2016.
The research collaboration expanded or extended again through 2019. This continues to be a very fruitful relationship between our companies, as evidenced by the breadth of activities in R&D. Key milestones, phase II data from patients with SMA in this quarter, Q2, other data from these mid-stage studies in the second half of the year. Now I'll wrap up with a brief overview of our corporate financials and outlook. As we recently reported our Q1 financials, you can see we have over $250 million on the balance sheet, representing between two and three years of cash, even as our net burn this year is expected around $100 million. That's a little bit misleading in as much as there are some non-recurring items in that burn, including about $18 million that we are paying to Amgen as a co-funding commitment towards our goal of 40.
That'll conclude this year, as well as there are some significant seven-figure wind-down costs associated with the closure of the VITALITY study. Net $100 million guidance, we're within that guidance, we're consistent with that as we peer out, even with that representing still over 24 months of cash based on that guidance. You can see about 54 million shares outstanding, 65 million on a fully diluted basis. Currently, with the stock trading around $9, the company's market cap is about 2x cash, about $500 million in market cap. Key milestones this year, as I mentioned, both for omecamtiv and reldesemtiv, also with the advancement we expect of at least two compounds moving to phase I later this year, we're looking forward to lifting the veil on those programs at an R&D day we expect in the second half of this year.
We're proud of our pipeline. It's a pipeline that represents, we would argue, the very best in muscle biology, R&D, that continues at the company, we appreciate very much the persistent support of our shareholders as we continue to advance these compounds and others towards our goal of bringing them forward for patients suffering diseases of severe muscle dysfunction and weakness. With that, I'll close. Thank you for your interest in this presentation, open up the floor for any questions.
Good morning. Is this good? They're a little scattered, partially based on things I wrote down during the presentation. I'm a little unclear on the data monitoring committee for omecamtiv mecarbil that recently met. How does that relate to the interim analysis? Are those the same people, or do you do the analysis after you get information from the data monitoring committee?
These are independent activities as baked into the design of the study. The development program has an executive committee and a steering committee that lends oversight to all of the studies and activities. Each study has a data monitoring committee that is charged with reviewing unblinded data and with a particular focus to safety. The data monitoring committee meets with a regular cadence, and this was not their first meeting. They've met with some regularity to review the safety as well as other data to ensure that the study should be conducted. In other instances, with other companies and other studies, and as could be the case here but was not, the data monitoring committee could recommend, for instance, changing the dose or altering the way in which we titrate dose, et cetera. In this case, they did not. Rather, instead, continue the study as intended.
The interim analyses are driven by the accrual of events. Once a sufficient number of events that represent an adequate sampling of the data have occurred, you remember, this study is event-driven. We're looking at mortality and heart failure-related events like rehospitalizations. Once there's a critical mass of those, a formal statistical analyses are performed, as well as a review of safety to see whether or not the study should continue. That's something that's highly ordered with regard to a statistical plan. That's, as I mentioned, baked into the protocol and the plan. The first interim 2019 would be predicated around the potential early stopping were there to be no potential way the study could achieve its objectives, therefore would be stopped potentially for futility. We don't expect that should occur.
The next one would be based on the potential for such an overwhelming effect of efficacy that the committee may deem it unethical to continue the conduct of the study, therefore could conceivably recommend early stopping of the study.
That second one is in 2020.
Again, it's event driven, but based on our projections of the accrual of events, we expect it could occur in 2020.
Okay. With your co-promotion rights with Amgen, would those potentially, in your agreement with them, go to a company if they acquired Cytokinetics?
Very good question. Very sophisticated question. The economics of our deal travel with a potential acquiring party, and the co-promotion rights would not.
Okay. On to reldesemtiv. I think today was the first time I heard you say that without any hedging whatsoever, that it is more potent, which I'm assuming means milligram for milligram, than tirasemtiv.
There's different ways of assessing potency, and I'm probably the last person who should be addressing that specific question. What I'll say is that there's the biochemical potency where you're looking at it in artificial systems. There's also the in vivo potency and there's the potency with respect to in humans when you're also dealing with protein interactions and absorption. All of those things, to us, suggest that reldesemtiv is at least as potent as tirasemtiv as would be the case in humans in a study like we're doing now, and potentially more potent based on the fact that we expect more could be getting into muscle.
Well, I'm probably the last person who should be asking scientific questions, so we're in good shape. The question I then have is, the FORTITUDE trial has significantly higher dosages than the tirasemtiv trials. Potentially, these patients could be getting much larger dosages, assuming they tolerate it. A maximum of 900, I believe, in FORTITUDE for the highest titration group.
I wouldn't compare dose-to-dose between those. What I would say is based on, and I'll show you, come back to a slide in phase I. Based on exposures between, and this is not in the same study, it's the same protocol, but in different patients undergoing the same protocol. We were getting more force frequency response with reldesemtiv relative to tirasemtiv at exposures that were comparable, suggesting to us that it could be more pronounced effect at similar exposures in humans.
Okay. I guess what I'm not understanding is the highest titration group with tirasemtiv was 500 milligrams in VITALITY, and we have 900 milligrams in FORTITUDE. Those two numbers can't be compared in some sort of linear way.
I would not compare them in a linear way. What I would say is that the exposures that we were evaluating with tirasemtiv in clinical trials, we believe are nested within the exposures that reldesemtiv. We may be able to get to more pronounced force frequency response with the exposures we're assessing with reldesemtiv. Meaning, if it continues to demonstrate favorable tolerability, we may be able to uptitrate reldesemtiv to levels that would achieve higher force frequency response than were achievable with tirasemtiv.
Okay, that's very helpful. With the next generation drug that you're developing with Astellas, can you say whether it has the same mechanism of action as the prior drugs?
It does.
Okay. What benefits might you be looking for?
Benefits could include ways in which it might ultimately be studied, including indications that might enable us to build 2 separate business units, one directed to rare diseases, one directed to more primary care indications. There could be similar benefits in terms of cost of goods, ease of synthesis, and other things that might confer advantages down the road. It's our belief that it's always good housekeeping to develop a portfolio of these compounds recognizing the breadth of potential indications.
Okay, great. You believe the SMA data or headline, I mean, not all of it, but some of it will be announced prior to the June 16th meeting?
Either before or at. Absent having the data in our hands, it's difficult to know whether it would be prompting us to make a disclosure before the meeting or rather concurrent with the meeting.
Okay. I think that's all I've got. Thank you.
Excellent. More than last year.
I'll try to do better next time.
Appreciate it very much. Always very good questions. Appreciate your continuing interest and support. Do we have any other questions? There being no other questions, I'd like to thank investors here in attendance, as well as those listening in on our conference call for your continued support of our company. In 2018, we believe we're well-positioned to execute on our business objectives and to deliver on the trust of our stockholders and other stakeholders. We very much appreciate your continued support and interest. We look forward to keeping you updated on our progress and prospects throughout the year. Lastly, we're extremely grateful for the privilege to serve patients and caregivers who so importantly depend on our ultimate success. With that, I'll turn it back over to Pat Gage. Thank you very much.
Thanks, Robert. Thank you for providing an update on the important progress Cytokinetics is making on the development of our innovative portfolio of first-in-class muscle biology-directed drug candidates. 2018 is an important year for us to advance new compounds into development, expand the phase III clinical trials program for omecamtiv mecarbil, and begin to potentially chart a phase III development path for reldesemtiv, depending on results that emerge from our broad clinical trials program. We remain committed to the patients, caregivers, and shareholders who count on us to deliver continued progress against our goal of improving the lives and functionality of people living with diseases of impaired muscle function. I want to thank all of you who participated today in this stockholder meeting. There being no further business, the meeting is now adjourned at 11:20 A.M. Thank you.