Good afternoon and welcome, ladies and gentlemen, to Cytokinetics' First Quarter 2015 Conference Call. At this time, I would like to inform you that this call is being recorded and that all participants are in a listen-only mode. At the company's request, we will open the call for questions and answers after the presentation. I will now turn the call over to Sharon Barbari, Cytokinetics' Executive Vice President of Finance and CFO. Please go ahead.

Good afternoon and thank you for joining us on this conference call today. Leading today's call is Robert Blum, our President and Chief Executive Officer. Following Robert's initial comments, Andy Wolff, our Senior Vice President and Chief Medical Officer, will provide an update regarding our planned Phase III clinical development program for tirasemtiv, our first-in-class fast skeletal muscle troponin activator, which we are developing for the potential treatment of ALS. Afterwards, Fady Malik, our Senior Vice President of Research and Development will provide an update on our clinical development program for CK-2127107 or CK-107, our next generation fast skeletal muscle troponin activator, and our plans for our Phase II clinical trial in spinal muscular atrophy or SMA. Fady will then provide an update on the clinical development program for omecamtiv mecarbil, our first-in-class cardiac myosin activator, which is being developed for the potential treatment of heart failure. I will then provide a financial overview for the quarter and Robert will conclude the call with additional perspectives and comments regarding our future plans and key milestones for 2015. We'll then open the call for questions. Please note that the following discussion, including our responses to questions, contains statements that constitute forward-looking statements for the purposes of the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995, including but not limited to statements relating to our financial guidance and collaborations with Amgen and Astellas, to the initiation, enrollment, design, conduct and results of clinical trials and to other research and development activities. 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 most recent annual report on Form 10-K, our quarterly reports 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 on them as representing our views in the future. We undertake no obligation to update these statements after this call. Now I'll now turn the call over to Robert.

Thank you, Sharon and thank you to everyone on the line for joining us for this Q1 earnings call today. As we review activities from the first quarter of 2015, we are very busily preparing for the initiation of Cytokinetics first Phase III clinical trial. The initiation of a Phase III clinical trials program for tirasemtiv is a very important event for our company and importantly for the ALS community. As we believe this maybe the only international Phase III clinical trial expected to enroll patients with ALS in 2015. Data from our Phase II BENEFIT-ALS clinical trial showed that tirasemtiv was the first investigational drug candidate to have a statistically significant and clinically meaningful effect on measures of respiratory function and muscle strength in an ALS patient population. During the first quarter we had further interactions with each of FDA and EMA to review the results from BENEFIT-ALS and to further refine our plans to advance tirasemtiv into a Phase III development program. More and more, the urgent unmet need of patients with ALS is gaining media and other high visibility attention from the broader community. We are proud to stand together with patients and care givers in our relentless pursuit of what we believe can be the very first new medicine for patients with ALS to address respiratory and other functional endpoints. With that said however, we are keenly aware of setting proper and realistic expectations and as such we continue to engage cooperatively and collaboratively with the scientific and clinical community as well as regulatory authorities to conduct rigorously designed comprehensive and properly conducted clinical trials of tirasemtiv and that importantly build on prior peer reviewed studies. Only by working collaboratively with all stakeholders in the fight against ALS do we believe that the shared interest of…

Thank you Robert. As you may recall BENEFIT-ALS is a Phase IIb multinational double blind randomized placebo controlled clinical trial designed to evaluate safety, tolerability and potential efficacy of tirasemtiv in patients with ALS. The results of BENEFIT-ALS shows that treatment with tirasemtiv resulted in a specifically significant and potentially quite a meaningful reduction versus placebo in the decline of SVC, the slow vital capacity at each assessment time point over 12 weeks of double-blind treatment. These effects also favored tirasemtiv risk placebo in all pre-specified sub groups being examined and thus we believe the status to be robust. Vital capacity is a meaningful measure of respiratory function that treatment guidelines specifies should be used to determine important clinical decisions in the treatment of ALS and is also used to aid prognosis. Given these findings from BENEFIT-ALS and following discussions with neuromuscular and pulmonary specialists and regulatory authorities, we chose to advance tirasemtiv to Phase III. We believe that the ALS provides a solid foundation on which to plan next steps in the clinical development of tirasemtiv. The objectives for the Phase III development program are to confirm and extend the results observed in BENEFIT-ALS. The upcoming trial will be conducted in the same eight countries and most of the same treatment centers as BENEFIT-ALS. In this trial double blind treatment will continue for at least 48 weeks thus substantially expanding the treatment period relative to BENEFIT-ALS. The end points will include measures of clinical benefit related to respiratory function in patients with ALS. Including the facts on SVC but also including other functional assessments of respiratory and other skeletal muscles. We believe the information we have received from neuromuscular and pulmonary experts both in the United States and internationally, market research and regulators provides an actionable trial design and…

Thank you Andy. Turning first to the development of CK-107, our next generation skeletal muscle troponin activator partnered with Astellas. As Robert previously mentioned, I am happy to report that in the first quarter, we began the planning of a Phase II clinical trial to evaluate CK-107 in patients with SMA which Cytokinetics will conduct in accordance to an agreed plan with Astellas. As part of that planning process we engage leading to our muscular physicians who are expert in SMA to discuss and inform the potential design of this Phase II clinical trial. In addition we initiated formulation development and manufacturing activities in events of the planned trial. Like ALS, SMA is also an orphan disease and is one of the most common fatal genetic neuromuscular disorders responsible for infant death. We believe that direct activation of skeletal muscle may address neuromuscular weakness that characterizes SMA and could demonstrate effects on key functional parameters including breathing. Our Phase II trial will explore pharmacodynamic end points in patients with SMA. We expect to target for enrolment of those patients with SMA who survived adolescence with the disease but may have gradual and progressive weakness in the proximal muscles of the extremities resulting in mobility problems and other functional limitations. Few treatment options exist for these patients, resulting in a high unmet need for new therapeutic options to address functional limitations and modified disease progression. We believe that our approach to developing CK-107 in patients with SMA will be complimentary to the process being construed by other company. Turning now to the development of omecamtiv mecarbil, in the first quarter patient enrolment was completed in COSMIC-HF and to date over 275 patients or nearly two thirds of those enrolled in the study have already completed the 20 week duration of dosing…

Thank you Fady. As our press release contained detailed financial results for the first quarter 2015 I’ll refer you to that public statement for the details of our P&L and balance sheet. We ended the first quarter with 117.5 million in cash, cash equivalents and investments which represents over 20 month of going forward net cash burns based on our 2015 guidance. Our guidance includes estimated cost of a planned Phase III development activities for tirasemtiv in 2015 and 2016. Revenues for the first quarter of 2015 were $4.4 million compared to $8 million during the same period in 2014. Revenues for the first quarter of 2015 included 1.6 million of license revenues, 2.1 million of research and development revenues from our collaboration with Astellas, and $0.7 million in research and development revenues from our collaboration with Amgen. Revenues for the same period in 2014 included $2.1 million of license revenues and $5.2 million of research and development revenues from our collaboration with Astellas, which included a $2.0 million milestone for research activities. And $0.7 million of research and development revenues from our collaboration with Amgen. Our first quarter 2015 R&D expenditures totalled $9 million, from a program perspective for the first quarter approximately 71% of our R&D expenses were attributable to our skeletal muscle contractility research and development activities which included both expenses associated with tirasemtiv and CK-107, 16% to our cardiac muscle contractility activities, and 13% to our other research activities. We ended the first quarter in a strong financial position with sufficient cash free resources to execute on all of our development plans including our Phase III clinical trial for tirasemtiv. That concludes the financial portion of today’s call. With that I’ll turn the call back over to Robert.

Thank you, Sharon. So in summary the first quarter of 2015 was a period of intensive planning for Cytokinetics, preparing to conduct our first Phase III clinical trial that the company, requires us to critically evaluate CRO’s and to ensure all systems and standard operating procedures are compliant with applicable standards and best industry practises. We look to our upcoming Phase III trial of tirasemtiv as a key pivot point for the company and we’ve upgraded capabilities throughout the company. We foresee these changes potentially serving us well also as we prepare for potential Phase III activities alongside Amgen in 2016 for omecamtiv mecarbil. By the end of 2015 we look forward to having two clinical development programs advancing either in or to Phase III trials with another enrolling in the Phase II. Achieving those objectives in 2015 with novel mechanism drug candidates will put Cytokinetics on a top step of the ladder amongst biopharmaceutical companies. Moreover, ongoing collaborative research programs with each of Amgen and Astellas are advancing towards designation of development compounds. We believe Cytokinetics continues to execute effectively and prudently, scientifically, operationally, and financially in building a robust diversified pipeline of muscle biology directed drug candidates. Cytokinetics discovered compounds have now been the subject of over 50 clinical trials. We enter the next phase of our company’s development much like we’ve approached the conduct of our R&D activities, with sound, careful, and rigorous planning and with the continuity expertise and experience of seasoned industry veterans leading the way. Nearly every member of our executive team has worked together on these programs for over 10 years. That matters when a company is pioneering a new pharmacology. It’s important to Cytokinetics to also be good listeners and partners with the patient and disease advocacy groups for whom our drug…

[Operator Instructions]. And our first question comes from the line of Jason Butler with JMP Securities.

Good afternoon Jason.

Hi, thank you. Hey Robert, good afternoon. Thanks for taking the question. Just a question on the tirasemtiv Phase III program and the enrolment timeline, can you just talk a little bit about what you learnt from the BENEFIT study and how the dynamic would be with the new protocol, the run in period, etc. the inclusion-exclusion criteria. Just give us some information about how we should think about the enrolment timeline for the Phase III program, thanks?

Sure. So I’ll start and then I’ll turn it over to Andy. With regard to enrolment timeline based on what we know today and we are going back to nearly all of the centres that participated and enrolled patients in BENEFIT-ALS. So we think we have reasonably good calibration on their ability to recruit and enrol patients. But base total we know from that study of the design of the trial that we will elaborate on in the next few weeks, we’re expecting that the study is going to enrol over the course of what amounts to about six to nine months give or take as we’ll see with the first initiations. But I think that’s a reasonable assumption at this point. That would mean that the first patients would be completing their 24 week analysis to enable the possibility of data by the end of next year we hope. And again with the study design we will be able to speak more to that. As was pointed out we are also looking to learning's from BENEFIT-ALS in modifying the open label lead in and also the dose titration steps. I’ll turn to Andy maybe to speak about the rationale for that.

Right, so you may recall that in BENEFIT-ALS all patients received a week of open label treatment with tirasemtiv, a total daily dose of 250 milligrams per day given as the 125 milligrams slice daily for two reasons. The first was we expected and in that we demonstrated about 40% to 50% of those patients would experience a dizziness that was usually mild. And then based on previous early Phase II studies and began demonstrating in BENEFIT-ALS result, even if the patient continued treatment on tirasemtiv. So generally it goes away. This helps maintain the line so that the patient experience dizziness on tirasemtiv and it resolved after immunization. It really wasn’t possible to determine whether or not that is because the patient was withdrawn on that double-blind placebo or they just continued on tirasemtiv and the dizziness went away because it is really almost always does. The other reason was to eliminate from randomization the minority of patients who can’t tolerate even that starting dose. So I would say the lesson from BENEFIT-ALS is that the first purpose maintaining the blind worked pretty well. The second didn’t work as well as we would have liked it to. We lost 16% of the patients who began in open label before randomization. So while we would have preferred to have lost fewer, that is the time to have them drop out if they are going to drop out not after randomization. But as you know, we lost three times as many patients after randomization from tirasemtiv as from placebo. So we think lengthening that open label period from one to two weeks might help investigators and patients make better decisions about whether they are really in a position to tolerate whatever adverse experiences they maybe having and this time it would be not just for 12 weeks but for 48 weeks. We had a lot of kick back actually from our investigators that data rushed, and the patient felt rushed why don’t we get into the trial. And getting them another week to make that decision would probably yield better decisions. The other thing we found is that, we increased the dose strength benefit weekly and you could just see on every week as we were trying to pay we lose another. I mean it wasn’t even 10% but it was a chunk of patients from the tirasemtiv treatment arm. And again we think that is escalating more slowly so every two weeks may reduce the number of post-randomization drop out. So honestly we won’t know and so we do it and see, but it seems like a rationale approach to try to improve our [indiscernible] for these patients.

There is some other steps that we’ll elaborate on once the study design is announced. Let me also address some of the other issues relating to tolerability from BENEFIT-ALS. You might recall there was nausea, there was some weight loss, there is some other ways that we think we can address some of those matters. But that said, ALS trials are notorious for a high dropout rate and we are not going to eliminate the early terminations. This is a terribly devastating disease, patients will drop out for a number of reasons. We just want to give the drug a fighting chance to be able to demonstrate what we know are it’s -- functional effects, so we do think that the steps we are taking will go a long way towards addressing some of the issues we saw in BENEFIT-ALS.

Thanks Rob, that’s felt really helpful information. Just one last question for Sharon, sorry if I missed your prepared comments, but could you give us a sense of what your cash -- either in terms of timing or data point?

So what I did cover was we had $117.5 million in cash and that’s well over 20 months of going forward cash. And that includes what we have is the estimated cost of the Phase III clinical trial for tirasemtiv. We haven’t provided any other detail on that. The only thing I would clarify is that based on the revenue guidance that we had given before of the $40 million to $43 million in cash revenue, that does include $30 million of revenue that’s deferred, that’s the upfront payment. So that is deferred on a proportional basis over the achievement of the activities that are underlying there. So in other words the research activities for Astellas as well as the development activities and those aren't even spread over the next two years. They are kind of chunky.

It’s probably also worth nothing Jason that the guidance that Sharon is referring to does not include expectations relating to potential milestone payments that could be payable in 2015 and 2016. So we are focused just to those committed revenues from our existing collaboration agreements.

Okay great, thanks for taking the question and congratulations on the program.

Thank you, Jason.

Thank you Jason.

And our next question is from Charles Duncan with Piper Jaffray.

Hi Charles.

Hi guys, it’s actually Roy in for Charles, sorry about that. Just a couple of quick questions, can you guys tell us what’s the remaining discussion points with the FDA and the EMA on the Phase III for tira? A - Robert I. Blum So I don’t think there are any remaining discussion points per say. We are proceeding to initiate the study in the second quarter based on what we already know. So as we’ve laid out here on these calls in the past, interactions with regulatory authorities are continuing and we have ongoing interactions not only with respect to the protocol but also other matters. There are non-clinical and other things that warrant discussion with the FDA in order to best be positioned for a registration. So we imply that we are still awaiting any feed-back prior to readying for this trial, that’s incorrect. We are in fact proceeding to this study with expectation, it will dosage first patient in the second quarter.

Okay, that makes sense. And I guess that will be without a SPA, did you think about CSPA and what about breakthrough designation, do you intend to apply for that?

So we think about SPA, we think about breakthrough designation. We talk a lot about those things including with advisors and with regulatory authorities. We’ll let you know if that comes to be, but we are not going to on a call like this speculate about those matters.

Okay great and then about the co-development with Astellas, does that potentially apply that SMA Phase II, can you tell us maybe where you are leaning on that and if you opt in do you think that will give us greater visibility on the development of the candidate, thanks?

So with regard to the SMA study that’s a trial that is already agreed between Cytokinetics and Astellas. It is part of the development plan for which there is already a negotiated budget. We are performing that study and it will be at the expense of Astellas. We’ll start that study later this year. It will be enrolling with data expected afterwards but there is no option or uncertainty about whether that something that we intend to do. The co development option that we have with Astellas not unlike the one we have in our Amgen agreement speaks to our option downstream to co-fund certain development activities in order to buy up our royalty economics. But it’s not an option with respect to whether we are conducting development activities. With Astellas this Phase II study is already agreed. We will conduct it and they will reimburse our cost.

Okay, great. Thank you.

Thank you.

[Operator Instructions]. And your next question comes from Joseph Pantginis with Roth Capital Partners.

Hey Joe.

Hey guys, good morning. I mean good afternoon, sorry again, losing my track here, Robert since you’ve taken such as stereotypical route for the development of tirasemtiv with the clinical programs to date, can you talk to how that has been a potential benefit in your regulatory discussions. Of course one of the things that I am referring to here is other approach is that might be out there for ALS which might have different approaches to the FDA?

So the question is have we taken a more conventional route? I am not sure I understood what –

No, based on you taking the conventional route, how do you think that might have benefitted your regulatory discussions?

So I don’t want to get into a he said she said or what other companies are doing only to say what I think that Cytokinetics is doing well. So to answer your question what I will underscore is I think we are approaching FDA very thoughtfully with regard to an honest understanding of what our BENEFIT-ALS trial teaches us both the good and the bad frankly and candidly we recognize if there is some things that we want to improve upon from BENEFIT-ALS as we approach Phase III. We went into our end of Phase II meeting with FDA much like with EMA somewhat sober to the reality of what are those issues that we were contending. We had a study that was a very large eight country international trial, we believe the largest Phase II study ever conducted at ALS. But however, it missed on its primary efficacy endpoint and there is no denying that we prospectively defined that ALSFRS-R would be the primary endpoint. Unfortunately the study we don’t believe was of sufficient duration and for other reasons, the drug did not move that endpoint. That will be an endpoint that will assess as a secondary endpoint in Phase III but we will go with what we learnt from BENEFIT-ALS and it seems that the most meaningful clinical effect was on our respiratory function and a slowing in the decline of respiratory function we think and I think FDA and EMA have echoed could be very meaningful to these patients. Ultimately they die of respiratory failure and pneumonia in most cases. So we’ve been approaching this series of regulatory interactions in a way that is very scientifically rigorous, that has the benefit of outside advisors and consultants who’ve accompanied us to the meetings with regulatory authorities, and I think in working with the largest network of clinical trial investigators in ALS we have credibility that hopefully will afford us more constructive interactions.

Now that’s helpful, thank you. And you might probably will defer the next question to the R&D Day next week but was just curious to see based on the language on your call and in the press release about what some of the other measures we might be looking at with regard to respiratory functions since SVC is the primary endpoint I am assuming?

So I’ll turn that over to Fady to answer.

Yeah, I mean I think SVC is a quantitative measure breathing function but there are sort of milestone metrics in terms of peoples respiratory function that you can imagine as well. Such as their use of assisted ventilation in either night time or full time. There are questions in the ALSFRS-R that are specific to respiratory function that one can focus on and so some of the secondary endpoints will are constructed from those clinical measures to respiratory function.

This is where it's especially important to note that’s a little vital capacity or vital capacity in general is used very routinely by researchers but also by clinicians who are managing the treatment of ALS to guide prognostic and interventional decisions. And as such the guidelines are very clear about the role vital capacity plays in the things that Fady was mentioning. So we think there is congruence of interest with respect to our stated objective which is that the Phase III study should confirm and extend the findings from BENEFIT-ALS.

Great, thanks a lot guys.

Thank you Joe.

Your next question is from George Zavoico with Jones Trading.

Hey George.

Hi Robert, Hi Sharon it’s George Zavoico, not Zovocio but I get that all the time. A quick question about the safety issue and the drop out Andy that you referred to, the dropout rate of patients in BENEFIT-ALS. You said that the key times or the times when most of the patients dropped out was during the lead in and the during the dose escalation. Now you’re going to extend the treatment period in the Phase III trial, perhaps even double it, once the patients have stabilized on a dose can we expect that to be fairly stable and with few drop out patients dropping out?

That really is exactly what we observed in BENEFIT-ALS that once patients got past dose titration and recall and benefit they were allowed to down titrate. And you may recall that although we attempt to get all the patients to 500 milligrams a day, in the end those who completed the study about half of them were on 500 and about a quarter were on 375 a day and a quarter on 250 today. At those doses and with that distribution of doses, once we got past week four or five, the dropout rates between placebo and tirasemtiv were pretty parallel.

Okay, that’s a good sign and I guess hopefully a good present for the Phase III trial. And a little bit about potential trends that you mentioned you have pretty much broken up the ALSFRS-R into its individual components. Have you looked at BENEFIT, if you looked at the individual components in BENEFIT-ALS and I can't remember if there are any potential trends that showed potential benefit that with a larger trial, with longer treatment, it might emerge as significant in terms of quality of life and function.

Right, well we didn’t actually in BENEFIT-ALS and something you may have seen us present is there are two things that I think really contributed to that. First of all our entry criteria resulted at a population of patients whose slow vital capacity at baseline was almost 90% of predicted. So practically normal. Almost all of them were scored as four which as you know is no deficit on the respiratory insufficiency and/or dyspnea items in the ALSFRS-R and the great, great majority of them were four on question number nine, dyspnea. So those are the three elements. So even with the big difference and the decline in vital capacity between drug and placebo, it still wasn’t long enough that you might expect any of them to drop down a level and in fact that’s what we saw. Most of the patients were scored as four coming in and this is on tirasemtiv and placebo and most of them were scored as four coming out. Now as you suggest, in a trial of a longer duration I think we may see a difference between tirasemtiv and placebo in the number of patients who drop a point or more on those respiratory domains of the ALSFRS-R.

Okay thanks Andy, let’s hope that turns out that way. Thanks.

Yes, definitely.

We have no other questions in queue at this time. And I would like to turn the call back over to Mr. Blum.

So, I want to thank everybody for their participation in our call today. Clearly the first quarter was a very busy one for us especially in light of planning for the initiation of the Phase III study, tirasemtiv to occur in this second quarter but also across the company and in connection with activities directed, to omecamtiv and also CK-107. We are expecting it to be a big year and we look forward to updating you on progress throughout the year. We hope that you will be able to attend our R&D Day on May 12th. It will be in New York, at the Hyatt Grand Central and any questions please direct them to us at investor relations here at the company. With that I will end the call, thank you for your interest in Cytokinetics and we look forward to being in touch.