Cytokinetics, Incorporated (CYTK) Q1 2013 Earnings Report, Transcript and Summary

Good afternoon, and welcome ladies and gentlemen to the Cytokinetics’ First Quarter 2013 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 request of the company, 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 Chief Financial Officer. Please go ahead.

Good afternoon and thank you for joining the Cytokinetics’ senior management team on this conference call today. Also present during this call are Robert Blum, our President and Chief Executive Officer; Dr. Andrew Wolff, Senior Vice President of Clinical Research and Development and Chief Medical Officer and Dr. Fady Malik, Senior Vice President of Research and Early Development. Following the forward-looking statement disclaimer, Robert will provide an overview of the past quarter, highlighting advancements in our clinical development programs. Fady will then update you regarding recent progress in our clinical development of omecamtiv mecarbil for the potential treatment of heart failure, and Andy will then detail recent progress in our clinical development of tirasemtiv for the potential treatment of ALS and other neuromuscular diseases and he will also provide an update relating to CK-2127107 or CK-107, our follow-on fast skeletal muscle activator. I will then provide a financial overview and comments with respect to our cash position and details on our investments in research and development activity. Robert will then conclude the call with additional comments regarding recent activities and expected next-steps and projected milestones for 2013 for our development stage programs. We’ll then open the call for questions. The following discussion, including our responses to questions, contain statements that constitute forward-looking statements for purposes of the Safe Harbor provisions of the Private Securities Litigation Act of 1995, including but not limited to statements relating to our financial guidance, incorporate partnering 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 report on Form 8-K. Copies of these documents maybe 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 presenting our views in the future. We undertake no obligation to update these statements after this call. I'll now turn the call over to Robert.

Thank you, Sharon. 2013 is proceeding as planned to be a very important year for Cytokinetics. We anticipate that data from our two Phase IIb clinical trials will in form the progression of our most advanced programs into potential Phase III trials. The first quarter demonstrated our progression towards these key milestones and our movement forward towards potentially meaningful value inflection points for the company. Let me take a brief moment to highlight each of these milestones in a bit more detail. During the last quarter, we reported that completion of enrollment in the third and final cohort in our Phase IIb clinical trial, ATOMIC-AHF which stands for acute treatment of omecamtiv mecarbil to increase contractility in Acute Heart Failure. It is particularly exciting for us to know that we will soon have clinical data that may allow us to assess the safety, tolerability, pharmacokinetics and pharmacodynamic effects of omecamtiv mecarbil in a high risk population of patients hospitalized with acutely decompensated heart failure. Together with our partner Amgen, we are readying to lock the database to enable prospectively defined statistical analysis which we hope may demonstrate that omecamtiv mecarbil is both well tolerated and also shows clinically relevant effects in this rather sick population. Most importantly, we hope that ATOMIC-AHF will provide support of the evidence for advancing omecamtiv mecarbil into Phase III. Once the full results from ATOMIC-AHF are reviewed together with Amgen, we look forward to reporting the findings from this Phase IIb to be clinical trial; we continue to anticipate those results to be made public in mid-year 2013. Underscoring further progress and an expansion of activities in our heart failure program, last month we announced the initiation of another Phase II clinical trial of omecamtiv mecarbil called COSMIC-HF which stands for Chronic Oral Study of Myosin Activation to Increase Contractility in Heart Failure. This trial is evaluating the pharmacokinetics of three oral formulations of omecamtiv mecarbil in patients with heart failure and left ventricular systolic dysfunction. We expect the results of this clinical trial to inform the selection of one of these oral formulations for possible advancement into the Phase III clinical program. Fady will give you more color on the development of omecamtiv mecarbil in a few minutes, but I believe it is fair to summarize that 2013 offers much promise for the development of this novel drug candidate and we are working closely with Amgen to ensure that results can be available from ATOMIC-AHF and COSMIC-HF to inform next steps towards potentially going into Phase III. Now turning to our skeletal muscle contractility program. In the last quarter, we made very good progress in our Phase IIb clinical trial BENEFIT-ALS which stands for Blinded Evaluation of Neuromuscular Effects and Functional Improvement with tirasemtiv in ALS. The initiation of clinical trials sites and enrollment of patients are both proceeding well. To remind you, we initiated patient dosing in this trial in November 2012 and since then have been busily adding additional sites to enrollment in the United States, and Canada and in five European countries. Patient enrollment has rapidly followed and I am proud to today that we have enrolled over 200 patients in this trial which may represent the most advanced clinical trial now underway for the potential treatment of ALS patients. Andy will report on impressive progress in BENEFIT-ALS as well as a protocol amendment that we will be implementing to ensure we maintain the statistical rigor that we originally intended for this important clinical trial. We continue to believe that we are on target to complete BENEFIT-ALS and present clinical data by the end of 2013. Lastly, in April, we announced the initiation of a Phase I clinical trial CY 5011 which is the first time in human clinical trial of CK-2127107 or CK-107 in healthy male volunteers. Like tirasemtiv, CK-107 is a novel small molecular activator of the fast skeletal muscle troponin complex discovered as a result of Cytokinetics’ optimization of a different chemical series that now which produced tirasemtiv advancing CK-107 into Phase I evaluation in healthy subjects is consistent with Cytokinetics’ corporate strategy to characterize a potential follow-on compound to tirasemtiv in humans and to enable the future evaluation of fast skeletal muscle troponin activation in a potentially broader set of clinical indications and beyond ALS. With that introduction, I will now turn the call over to Fady to elaborate on the recent progress that we've achieved with omecamtiv mecarbil and later in the call I will turn to provide additional perspectives relating to our future plans.

Thank you, Robert. As Robert mentioned I'm happy to share good news regarding the development of omecamtiv mecarbil. Together with Amgen we have made encouraging progress during the past quarter with the development of each of the intravenous and oral forms of omecamtiv mecarbil. We are pleased that the ATOMIC-AHF trial has completed patient enrolment of the third and final cohort this past quarter. To remind you ATOMIC-AHF is an international randomized double blind placebo controlled Phase IIb clinical trial of intravenous formulation of omecamtiv mecarbil in patients hospitalized with acutely decompensated heart failure. Study enrolment increased the momentum over time and with each successive cohort enrolling faster than the previous cohort. During the enrolment phase of ATOMIC-AHF, the Data Monitoring Committee or DMC convened a predefined interim points including following completion of cohort 1 and 2 and during the conduct of a third cohort. At each DMC meeting, the committee reviewed unblinded safety data in considerable detail, but we at Amgen remained blinded at this time. The demographics and baseline characteristics of those patients enrolled in ATOMIC-AHF point to a fairly sick, acute heart failure patient population. We find it encouraging that the DMC allowed the state to complete according to plan without recommending changes to doses of omecamtiv mecarbil. Let's speak to our most important clinical development objective to be formed by the study, which is to assess the safety and tolerability of omecamtiv mecarbil in these most vulnerable patients. While we will also be looking for potential signals of clinical efficacy in the secure heart failure population such as improvements in the primary efficacy endpoint of (inaudible) relief or in other secondary end points. In our view most critical to the potential progression of omecamtiv mecarbil to Phase III will be the safety and tolerability assessments in this highly monitored acutely ill heart failure patient population. In addition to the progress made in closing enrolment of ATOMIC-AHF as Robert mentioned, we also recently announced the initiation of COSMIC-HF a Phase II, double blind, randomized placebo controlled multi-center dose escalation study designed to evaluate three modified release oral formulations of omecamtiv mecarbil in patients with heart failure and left ventricular systolic function. Enrolment is continuing the first cohort of the dose escalation phase of this trial and clinical trial sites are being initiated in several countries. As enrolment progresses, we will be in a better position to comment on when we might expect to proceed to the next cohort and to remind you, the trial will be conducted in two phases. First is the dose escalation phase which will compare the pharmacokinetic profiles of three oral formulations of omecamtiv mecarbil. First the 25 mg b.i.d. in cohort one and then 50 mg b.i.d. in cohort 2 dose for seven days. In the second phase an expanded cohort of 300 heart failure patients will be randomized to one of these three oral forms of omecamtiv mecarbil at either of two selected doses or placebo for three months. This international trial is anticipated to inform our understanding of the oral pharmacokinetics and longer term safety and intolerability of omecamtiv mecarbil in chronic heart failure patients. In addition, we will have the opportunity to evaluate the potential for sustained pharmacodynamic effects and their relationships with pharmacokinetics of this drug candidate. Additional information on clinical trials of omecamtiv mecarbil can be found at www.clinicaltrials.gov. And with that update on clinical development activity for omecamtiv mecarbil in the first quarter; I will turn the call over to Andy for an update on our skeletal muscle contract facility program.

Thank you, Fady. Last quarter was indeed exciting for the development of omecamtiv mecarbil and the same can be said of both drug candidates in our skeletal muscle program. To begin, on February 25, my Cytokinetics colleagues and I attended an important FDA public hearing on the illness. We were impressed by the FDA’s engagement with the very motivated patient and efficacy community. We were all very moved by hearing patients with ALS describe the impact of their disease and their appreciation for their caregivers and the clinical community. These patients made impassioned pleas to FDA relating to their interest in participating in clinical trials and in evaluation of new drugs to treat this devastating disease. At Cytokinetics, we feel our development of tirasemtiv maybe responses to the shared interest of FDA and patients with ALS and are optimistic that the results will benefit ALS may offer meaningful hope. To remind you, BENEFIT-ALS is a Phase IIb multinational, double blind, randomize placebo control, clinical trial design to evaluate the safety, tolerability and potential efficacy of our fast, skeletal muscle troponin activator tirasemtiv in patients with ALS. Over the last quarter, as Robert mentioned, we made significant progress in BENEFIT-ALS. To-date over 200 patients have been enrolled and dozens have now successfully completed three months of treatment. The trial enrols patients to what we randomize one-to-one to receive 12 weeks of double-blind treatment with either tirasemtiv or placebo. All enrolled patients receive treatment with open label tirasemtiv at 125 milligrams twice daily, prior to randomization in order to ensure that randomized patients can tolerate that dose of tirasemtiv and also to minimize the potential for unblinding treatment due to generally mild adverse events that if observed tend to occur early during treatment with tirasemtiv and then usually resolve by the second week of continued treatment. BENEFIT-ALS was originally designed to enrol approximately 400 patients randomized one-to-one to receive 12 weeks of double-blind treatment with tirasemtiv or placebo. Recently however, our review of the double-blinded aggregate data from the trial indicated that the standard deviation about the primary end point which is the change from baseline in the ALS functional rating scale in it's revised form, or ALSFRS-R is actually slightly higher than the estimate we use to calculate the sample size for the study. That original estimate was based on data from the North Eastern ALS or NE-ALS database which includes several reasons completed clinical trials in ALS patients. Consequently, in order to preserve our intended statistical power, we are amending the protocol to allow us to enrol approximately 500 patients or about a 100 more than we originally planned. Taking into account that some patients will terminate during the open enrolment phase and others during the post randomization phase, we expect that approximately 400 patients will complete all 12 weeks of treatment with double-blind study drug. Clinical assessments take place monthly; during the course of treatment patients also participate and follow up evaluations at 7 and 28 days after their final dose. In addition to the primary endpoint, the ALSFRS-R secondary endpoints include Maximum Voluntary Ventilation or MDV and other measures of skeletal muscle function. It is not unusual to submit a protocol amendment to reflect observations in an ongoing clinical trail and we believe that are doing so can improve the opportunity for us to increase the statistical power of benefit ALS, while also adhering to our original timeline for trial results. I will now turn to another key first quarter even from our clinical development program for tirasemtiv, which was our recent report of data evaluating tirasemtiv in patients with myasthenia gravis. The third patient population and which we have demonstrated pharmacodynamic affective this drug candidate. Last month we announced that data from our phase IIA evidence of affect clinical trail of tirasemtiv in patients with generalized myasthenia gravis or MG know as CY 4023 were presented at the American Academy of Neurology Meeting in San Diego. CY 4023 was a double blind randomized three period cross-over, placebo controlled, pharmacokinetic and pharmacodynamic study evaluating single doses of tirasemtiv. (Inaudible) Tirasemtiv was associated with statistically significant dose related increases in skeletal muscle endurance in patients with MG as assessed by the quantitative MG score. We are encourage by this data as they further extenuate the potentially broad clinical application of fast skeletal muscle activation. As a reminder this clinical trail and preclinical research on tirasemtiv in MG was funded by a grant from the National Institute of Neurological Disorders and Stroke. Lastly, as Robert also mentioned, we recently announced the initiation of CY 5011, a Phase I first-time-in-humans clinical trial of CK-2127107 or for short CK-107 in healthy male volunteers. CY 5011 is a double-blind, randomized, placebo-controlled study designed to assess the safety, tolerability and pharmacokinetics of single ascending oral dosage of CK-107 administered to healthy adult males in the three-period dose escalating crossover design. The primary objective of this study is to determine the safety and tolerability of single doses of CK-107 administered orally to healthy male volunteers. The secondary objective is to evaluate the pharmacokinetic profile of single doses of CK-107. Putting a second fast skeletal muscle activator into clinical trials further underscores the opportunity for Cytokinetics to diversify chemical and pharmaceutical risks as well as to potentially broaden the clinical landscape associated with our pioneering development of an entirely new pharmacology for fast skeletal muscle activation. As always, additional information about our completed or ongoing clinical trials can be found at www.clinicaltrials.gov. With that update on our clinical development activities, I will turn the call over to Sharon.

Thank you, Andy. As our press release contains detailed financial results for the first quarter 2013, I'll refer you to that public statement for the details on our P&L and balance sheet. As you can garner from our discussions thus far, during the past quarter we have been focused on deploying our capital resources on the progression from our skeletal muscle contractility program, in particular our BENEFIT-ALS trial. We ended the first quarter with approximately $61.6 million in cash, cash equivalents and investments which represents over 14 months of going forward net cash burn based on our 2013 financial guidance. Our first quarter 2013 R&D expenses totaled $9.8 million. From a program perspective, for the first quarter approximately 74% of our R&D expenses were attributable to our skeletal muscle contractility research and development activities, 6% to our cardiac muscle contractility activities and 20% to our other research activities. In 2013, we anticipate focusing our financial resources largely under progression and completion of our BENEFIT-ALS clinical trials. We believe that this program together with our cardiac muscle contractility program partnered with Amgen represents opportunities for near-term value generation for the company, as both are expected to generate key Phase IIb trial result in 2013. That concludes the financial portion of today's call. With that, I will now turn the call back over to Rob.

Thank you, Sharon. We are very pleased with the progress that we made in the first quarter. As we look at what 2013 holds for Cytokinetics and the potential advancement of both of our first-in-class muscle contractility programs, we are proud of our execution of key development activities, which accompanies the high quality science that led to the discovery of our drug candidates. Our mission to define an entirely novel pharmacology rooted in the mechanics of muscle contractility and function has already yielded pharmacodynamic evidence, supporting our therapeutic hypothesis that activating cardiac myosin can improve systolic function reflected by increases of stroke volume and ejection fraction in heart failure patients. Similarly, we have observed that activating skeletal muscle troponin results in an increased muscle power, force and endurance that may preserve or prolong independence and the quality of life in patients with ALS. We look forward to ATOMIC-AHF and BENEFIT-ALS results in 2013, hopefully providing support for continued advancement of our two programs into Phase III clinical development. We proudly assume the leadership for what we hope will be the next key advances in the care of heart failure in ALS patients. The fact that FDA recently held up public hearing to obtain inputs from stakeholders on the needs and preferences of ALS patients and their caregivers is evidenced of the high visibility attention FDA is affording the development of new medicines for ALS. We are encouraged that FDA is actively soliciting input on a scientific evaluation, marketing, authorization and post-marketing surveillance of potential products to diagnose or treatment ALS. We look forward to participating in the constructive dialogue regarding the development of potential new therapies for ALS. Similarly, the EMA has been a soliciting public commentary on alternative ways to led regulatory oversight to developing next generation medicines for each of ALS as well as heart failure. We believe that both of Cytokinetics later-stage clinical development programs are well-positioned for high visibility and hopefully high impact in therapeutic areas that could surely benefit from innovation to afford patients and their families better treatment outcomes. Now let me turn to our respective milestones for 2013. For omecamtiv mecarbil, in mid-2013, we expect to report results from ATOMIC-AHF. For tirasemtiv, by mid-2013 we anticipate completion of enrollment in BENEFIT-ALS, and by the end of 2013 we expect to report results from BENEFIT-ALS. With clinical trials data expected from each of ATOMIC-AHF and BENEFIT-ALS in 2013, we are pleased with Cytokinetics progress and execution in the last quarter and we remain hopeful for their implications for bright future for our company and shareholders. That concludes the formal portion of our call today. And operator, I would now like to open up the call to questions please.

(Operator Instructions) Our first question comes from Simos Simeonidis with Cowen & Company. Your line is open. Simos Simeonidis - Cowen & Company: Hi everyone. Thank you for taking the questions. First, I would like to ask about the amendment to the protocol, and first of all the only change is going to be the increase in size of the trial, is that correct?

So right now, what we are able to share with you is a change as it relates to the enrollment, that will be going from a targeted initial enrollment of 400 to what now will be 500 patients. In order to get there, we may consider some other changes in the eligibility criteria, but that’s not yet something that we have latching on, but I do believe that the key information today relates to the change in the enrollment. Simos Simeonidis - Cowen & Company: Okay. And then you said that the powering is going to be maintained as prior to this change, correct?

That’s right. Simos Simeonidis - Cowen & Company: And you are shooting if I remember correctly for roughly a 20% to 25% improvement in the revised ALSFRS?

So precisely, what we are powering the study to do is to have 80% power [to the fact] that difference in the change from baseline in the ALSFRS-R between tirasemtiv and placebo of 1.18 points, that's actually little more on a percentage basis. Simos Simeonidis - Cowen & Company: Okay. And then trying to understand this, how you got to this difference in the -- it was rather to this change in the protocol, I mean is it something special about this patient population you are enrolling, because you are using recent NEALS trials to get your estimate, I mean are you surprised that there is a slightly higher deviation from the primary endpoint?

Not really. And let me give you some perspective on what a small different it actually is, the database that we used provided us with an estimate around the change from baseline, from baseline to three months I should say in the ALSFRS-R around four points, so four points standard deviation. And what we are seeing on our own database which I want to emphasize is looking at the aggregate data in a blinded fashion, so we are looking at is a variability in this change from baseline, it’s not segregated by tirasemtiv versus placebo because the data are not unblinded, we are seeing a standard deviation of around 4.2 or 4.3 points. So it’s not a huge difference. Our entry criteria are not exactly the same as those in earlier studies and one of them that, I know patient with ALS appreciate very much is we not have a maximum criterion for how long the patients may have had the disease before they can enroll. So to some extent, we have been willing to enroll somewhat sicker patients than earlier trials and that may contribute to the variability or it may just literally be variability in the variability and in the second half of the trial we might find those patients have an overall standard deviation about their change from baseline of 3.8 and at the end of the day we will have an (inaudible) of four. But we can't know that right now and so I think the prudent thing to do is to provide for enrolling a few more patients so that we can wind up with about 400 complete.

And (inaudible) gets to the crux of the matter and I think to underscore something else we said in our prepared remarks, we think that this is an appropriate step to take to maintain the same statistical rigor and at the same time complete enrolment in the same timeframe and as you can also conclude within the same budgetary envelope. Simos Simeonidis - Cowen & Company: That was going to be my next question. Robert you mentioned that the timing is going to be the same and I know that you know this being one of the most advanced or if not the most advanced trial, enrolment has been really picking up. So even though you are adding a 100 patients you are still going to finish at the same time and there is no additional cost to enroll additional patients.

There would be an additional cost of enrolling the patients but we think we can absorb that cost within the same budget that we initially assigned to the study, and yes we do believe that we will be in a position to complete enrolment in the same timeframe as originally projected.

We are maintaining our guidance that we have provided on our fourth quarter earnings call. So we are probably being more at the upper end of that guidance from an operating expense standpoint but we are still within the envelope. Simos Simeonidis - Cowen & Company: And then quick one on the omecamtiv mecarbil and I'll jump back on to the queue. So once we have the ATOMIC data in the middle of the year, can you walk us through what are the next steps before you can go to a you and Amgen can go to the combined Phase III trial with an IV and oral formulations before you can design and initiate that. Is the only step that's left to wait for the COSMIC data and if that's the case, how long is the time between ATOMIC read out and COSMIC read out. I know that's not a simple answer because you have the dose escalation that's ongoing with COSMIC, but can you help us understand from the time at the middle of the year you have ATOMIC until you can start Phase III assuming both ATOMIC and COSMIC are successful, how long is the time and what are the intermediate steps. Thank you.

It’s a very good question, I'll do my best to try to answer and also ask Fady to help me out, I hope that this will be deemed satisfactory. Obviously there are things that we can't know today and also these are discussions that must be had with Amgen of course. What I will say is that with ATOMIC concluding this summer, we do hope that we will be in a position to have data that we can suggest will inform the potential progression to Phase III. But certainly as we've been quite public, our Phase III plans contemplate both the intravenous and the oral forms of omecamtiv mecarbil and we therefore will need the cosmic data to inform the ultimate design of Phase III, and as you could anticipate what would then be a need for an end of Phase II meeting prior to entry in to Phase III. We have not committed to specific timelines and I can’t speak for that especially in light of the fact that those are decisions made jointly with Amgen, but what I can say is that with COSMIC enrolling, we think that we will have information that will inform that progression. When COSMIC concludes, I can’t know, with more patients enrolled, we hope to be able to give more concrete guidance and then from there, together with Amgen, we can perhaps construct scenarios under which we might begin Phase III. I am thinking that’s the best I can do for you today.

Your next question comes from Charles Duncan with Piper Jaffray. Your line is open.

So, my first question is on tirasemtiv. Getting back to this variability, it seems like you are increasing the size of the study by roughly 25% on the initial projections of approximately 400 patients. So is there an equivalent or a similar difference in the variability of ALS FRS than you had originally projected or are you in a fact actually increasing the power of the study as well.

We're actually undertaking this to maintain the power that we originally intended to have, and to actually amplify this further on what's driving this, and we did reference this briefly in our prepared comments, but it is partly, because the standard deviation about the change from baseline and ALSFRS-R is a little bit bigger than we used when we calculated our sample size. It's also because the dropout rate from the open label and then post randomization is a little bit higher than we had projected as well. We expected about 10% dropouts from randomized patients or actually running a little bit under that, but we ran little bit over the number of patients that aren’t completing the open label phase and being randomized. So we believe that by randomizing 500 patients, we should complete 400 that will go through the 12 weeks of double-blind treatment and that 400 with a slightly higher standard deviation that we are seeing in the patients enrol today, we believe will keep the same statistical power that we originally intended to have and that is 80% power to detect a difference between tirasemtiv and placebo in that primary end point or 1.18 points.

And let me ask you about the [trap-up] between our randomization and enrolment, is that do you think that’s the function of tolerability of tirasemtiv or do you think that’s the function of may be there is severity of disease or the state of the type of patients that you are enrolling?

I think it's a combination of many things. There are some patients you really do have adverse events that may be well related to tirasemtiv, and then another patient may find them not problematic than this patient does. There are other reasons why patients have dropped out from the open-label that aren’t related to tirasemtiv tolerability and whatever the reason if they come out for from open-label, they don't give randomized so, but it isn't all tolerability to tirasemtiv, some extent it is, in some cases the diseases maybe a little more severe, the patients get into the trail and just decide that it’s more effort then they want to extent, had a couple of issues with patients not being able to swallow the blinded products, so it’s a mismatch of things.

And then this may sound a little Pollyanna, but is there any -- I mean I understand that this is a blinded look, but could you have larger variability due to bigger differences between the two arms?

Probably not, generally speaking it’s a common standard deviation and it’s unusual actually for the two treatment groups to wind up having different standard deviations. I know that sounds a little bit counterintuitive but I have been through it enough times, with enough differentiate PHT levels statisticians that I can assure that’s not likely to be the situation.

Okay, thanks for that added color. Let me ask one quick question on omecamtiv and it’s kind of related to the financial projections. We are not projecting any milestones yet this year, but it seems like consensus might be projecting a milestone this year. Is it the case that you would generate a milestone payment from Amgen if the omecamtiv moves forward in the Phase III? And just to be clear, I think what you have said Robert was that, you probably need both ATOMIC and COSMIC to inform progression into Phase II for the drug?

I'm sorry I'm not able to comment on what triggers milestone payments nor in that way would I be able to comment on whether the consensus that you are referring to is correct or not, I am sorry. What I can say is that, as we've been quite public in conversations with Amgen, it’s also been confirmed is that we together believe that the best opportunity is to develop both an IV and an oral form of omecamtiv in concert as part of an integrated regimen in Phase III clinical study and in that regard both ATOMIC and COSMIC are rate limiting to entry into Phase III.

Okay, thanks for that added color and looking for to the ATOMIC results midyear.

Your last question comes from Jason Butler with JMP Securities.

I just wanted to ask another follow-up on the tirasemtiv data that you are looking at, when you are talking about a standard deviation. Does that data specifically include that dexpramipexole data from Biogen Idec and have you used that data to assess the standard deviation of the control group?

No, the NEALS database at that point in time did not include those data.

Okay. So is there any data we have from that trial that supports or contradicts the historical experience in these patients that you can use in your -- when you look at the design empowering assumptions of this trial?

I think the best data that we have are data from our trial. And as I said, we can look at the aggregate data in a blind fashion and see what the deviation about that change from baseline in the primary endpoint is. And quite frankly, I don't think the difference from what we assumed going in is sufficiently great to be worrisome. It’s not very different and I think what we are doing is actually with an abundance of caution. As I said, I'm going to repeat it, we may well get to the end of the study when we've enrolled all the patients and find that the overall standard deviation is 4.0, just as we originally estimated that it would be. But in the event that it is a little bit higher, I think what we are doing is the right thing.

What I suggest Jason is you might be referring to the fact that in Biogen Idec reporting of the dexpramipexole data, there are some indications that the rate of progression in ALSFRS-R might have been slightly faster than what had been historical norms or at least thought to be the historical standard for a population in ALS patients. That's not information that's factored into this decision. This decision really relates more to standard deviation within the population.

There are no further questions at this time. I'll turn the call back over to the presenters.

So thank you to all the participants on the Cytokinetics teleconference today. We thank you for your continued support and interest in Cytokinetics. With that operator, we can conclude the call.

This concludes today's conference call. You may now disconnect.