Cytokinetics, Incorporated (CYTK) Q1 2017 Earnings Report, Transcript and Summary

Good afternoon, and welcome ladies and gentlemen to the Cytokinetics’ First Quarter 2017 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 Diane Weiser, Cytokinetics’ Vice President of Corporate Communications and Investor Relations. Please go ahead.

Good afternoon, everyone, and thanks for joining us on the call today. Robert Blum, our President and Chief Executive Officer, will kick us off with highlights from the quarter. Then Andy Wolff, our SVP and Chief Medical Officer, will provide updates on VITALITY-ALS and VIGOR-ALS; Fady Malik, our EVP of Research & Development, will then provide an update on CK-2127107 or CK-107, and the ongoing and planned chemical trials in this program. Fady will also provide an update on the Phase 3 development program for omecamtiv mecarbil. Pete Roddy, our new SVP and Chief Accounting Officer, will then provide a financial overview for the quarter; and Robert will wrap things up with additional corporate updates, perspective, and upcoming milestones, before we open the call for questions. Please note that portions of the following discussion including our responses to questions, contain statements that relate to future events and performance rather than historical facts, and constitute forward-looking statements for purposes of the Safe Harbor Provisions of the Private Securities Litigation Reform Act of 1995. Examples of forward-looking statements may include statements relating to our financial guidance and goals, our strategic initiatives, our collaborations with Amgen and Astellas, clinical trials, and the potential for eventual regulatory approval of our product candidates. Our actual results may 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 10-K and 8-K. We undertake no obligation to update any forward-looking statements after this call. And now, I will turn the call over to Robert.

Thank you, Diane, and thanks again to everyone for joining us on the call today. This is our first quarterly earnings call since our CFO, Sharon Barbari announced her plans to retire. Before I formerly introduce Pete Roddy, I’d like to personally thank Sharon for her partnership with me and her tremendous contributions to the company over the past 12 years. Sharon has been a key member of our executive team and provided expert leadership and oversight to our finance, IT, and facilities groups. She brought a highly valued strategic perspective to guide our accounting, budgeting, forecasting, corporate development and R&D activities and she solidified a sound operating and financial foundation on which we’ve advanced our R&D activities in emerging commercial development plans. Under Sharon stewardship, we have effectively managed our cash and other resources and institutionalized appropriate control to ensure we are good stewards of investors risk capital, while we also raise even more capital from strategic partners than we did from equity investors. We wish Sharon the very best that are upcoming retirement and are pleased that she is agreed to consult with us on special projects moving forward. I’d now like to introduce you to Pete Roddy. Pete joined Cytokinetics recently as our Senior Vice President and Chief Accounting Officer. We’re thrilled to have Pete joined the team as he brings abundant expertise and experience in biopharmaceutical public company accounting and corporate finance, as well as across functional R&D operations and commercial planning from his career that spans over 35 years. Pete joins us most recently from Pain Therapeutics, where he served as Chief Financial Officer for 15 years and prior to that, he held Senior Accounting Operations and Finance positions at COR Therapeutics with acquisitions by Millennium Pharmaceuticals. We’re very pleased to have Pete now joined us as a member of our senior executive team. You’ll be hearing from him in just a moment. Moving now to highlights from the quarter. We began 2017 in a strong position and ended the quarter even stronger, having added to our financial resources while also advancing our multiple muscle biology programs and executing well in our regulatory and commercial readiness plans. VITALITY-ALS and VIGOR-ALS continue to make good progress. The last patients enrolled had completed the 24-week visits and were proceeding towards last patient, last visit projected to occur in the second half of the year. Moreover, nearly all patients completing VITALITY-ALS are choosing to continue into the open label extension trial. We also advanced our innovative collaboration with Origent Data Sciences and we look forward to contributing data from VITALITY-ALS to Origent’s machine learning model that may ultimately help accelerate future clinical trials in ALS by providing predictive algorithms and potential efficiencies of the conduct of the trials. Andy will have more to say about that. Notably we also recently open Cohort 2 in our Phase 2 clinical trial of CK-2127107 or CK-107 in adolescents and adults with SMA, which we’re conducting and collaboration with Astellas. We anticipate that Cohort 2 will enroll more quickly than Cohort 1 and we remain on track to report results in the second half of 2017. Next, GALACTIC-HF, the Phase 3 cardiovascular outcomes clinical trial of omecamtiv mecarbil in high risk patients with heart failure conducted by Amgen, in collaboration with Cytokinetics has proceeded with continued site activation and patient enrollment occurring around the globe, things appear to be on track in these early days. And finally, during the quarter, we sold Royalty Pharma at 4.5% royalty on potential future worldwide sales of omecamtiv mecarbil for $100 million, $90 million in cash and $10 million of which was in Cytokinetics’ common shares. We have exercised our option under our collaboration agreement with Amgen to co-invest in the Phase 3 development program for omecamtiv mecarbil and exchange for an increased royalty of up to 4% on increasing worldwide sales of omecamtiv mecarbil outside Japan. As we have explained co-investing at this highest possible level affords Cytokinetics the right to co-promote omecamtiv mecarbil in institutional care settings in North America, with reimbursement by Amgen expected for certain salesforce activities. A joint commercial committee will lead oversight to the commercialization program and a joint commercial operating team would then be responsible for the day to day commercial activities relating to omecamtiv mecarbil. We look forward to working with our colleagues at Amgen to advance commercialization planning. As you’ll hear the team elaborate momentum continue to across our programs and we’re enthusiastic about our progress and prospects for the balance of 2017. With that, let me now turn the call over to Andy and he’ll update you on tirasemtiv.

Thanks, Robert. As Robert mentioned in the past quarter, we continued conduct of VITALITY-ALS and enrollment of patients into VIGOR-ALS, our open-label extension trial of tirasemtiv, for patients who have completed VITALITY-ALS. We’re pleased to report that greater than 90% of patients who complete VITALITY-ALS are choosing to enroll on VIGOR-ALS. We believe that VIGOR-ALS may compliment VITALITY-ALS and generate additional safety and outcome data to support the potential registration of tirasemtiv for the treatment of the patients with ALS. During the first quarter, the data safety monitoring committee convened to review unblinded safety and efficacy data from VITALITY-ALS. Afterwards, they recommended we complete the trial without any changes to its conduct. The last patient now has proceeded through the 24-week visit, which is when the primary end point SVC is measured allowing us now to plan database – data analysis and reporting. We expect results from VITALITY-ALS to be reported in the fourth quarter of 2017, hopefully to occur at ALS/MND Annual Meeting in Boston, December 8 or 10. Additionally in collaboration with Origent Data Sciences, we announced the advance of our research collaboration to prospectively validate Origent’s machine based learning model to predict of course of ALS disease progression using baseline data from VITALITY-ALS. As a reminder, this collaboration is funded by a grant from the ALS Association to Origent, and is designed to enable the first respective validation of their predictive model in a clinical trial for ALS. Previously, the Origent model predicting both function and survival of ALS patients have been validated retrospectively using placebo data from earlier clinical trial including our Phase 2 trial BENEFIT-ALS. In this next phase of the collaboration Origent will seek to prospectively validate existing predictive model for a variety of measurements including the ALSFRS-R, as well as the respiratory growth and involved our sub scores , SVC and survival using baseline data from VITALITY-ALS. Screening and baseline data from placebo patients will be provided Origent and their predictions will be made in the absence of assets of the subsequent outcomes of these patients. After Origent’s predictions are completed, the outcomes will be given to Origent to enable comparison of actual data to previously escrow predictions. We remain hopeful that predictive algorithms generated by this collaboration may ultimately accelerate clinical trials in patients with ALS by allowing randomization many fewer patients to placebo supplemented by so-called virtual control arms based on these models. I’ll turn the call over to Fady, to provide an update on CK-107, our next-generation fast skeletal troponin activator, as well as an update on omecamtiv mecarbil.

Thanks, Andy. The most significant development relating to CK-107 was the recent start of Cohort 2 of the Phase 2 clinical trial underway in adolescents and adults with SMA. As you’ll recall this clinical trial is designed to assess the effect of CK-107 a multiple measures of muscle function in both ambulatory and non-ambulatory patients with SMA. The decision to proceed the Cohort 2 fall under review of data from the Cohort 1 by the Data Monitoring Committee. As Robert mentioned, we expect this Cohort 2 enroll more quickly than did Cohort 1 since investigator sites are now up and running, and we have since added sites in Canada. We also had support from Cure SMA as well as Muscular Dystrophy Association getting the word out to their constituents communication channels. We look forward to reporting results in the second half of the year and if this hypothesis generating trial generate positive data potentially to advancing CK-107 to a Phase 3 clinical trial and patients with SMA under our collaboration with Astellas. We are encouraged by the enthusiasm within the SMA community for nusinersen or Spinraza and believe potential treatment with CK-107 could allow SMA patients to live a longer and more functional life. Thereby amplifying muscle force, power and stamina despite residual muscle weakness and dysfunctions. Since CK-107 has a different mechanism of action we believe it may prove complementary to Spinraza. And potentially further improve muscle function and physical performance in these older patients still confronting on unmet need. Of note, we recently presented a poster containing pre-clinical data regarding the CK-107 at the MDA Scientific Conference in Arlington, showing that is improve muscle function and mouse models of SMA similar to Type II, Type III and Type IV. These male models exhibit significant nerve dysfunction and muscle atrophy as well as a decrease in maximum muscle force production. In two different mouse models CK-107 increased scale of muscle force production relative to placebo in response to neural stimulation low to mid range stimulation frequency indicating a calcium sensitizing effect of CK-107 in the scalable muscles of these mice and suggesting that CK-107 may be a viable drug candidate to improve muscle function in patients with SMA. Moving to the other clinical trials under our collaboration with Astellas, Astellas continue to enroll patients in COPD and then Phase 2 clinical trial of CK-107 during the quarter and progress plans to conduct a Phase 1b clinical trial to assess the effect of CK-107 in elderly adults with limited mobility. We anticipate dosing for this trial to begin in this second quarter of the year. Finally during the last quarter, we continued plans to initiate a fourth clinical trial of CK-107. This one in patients with ALS, which we will conducted Astellas’ expense under our collaboration. We’ll have more to say about this trial as we get closer to steady start in mid-2017. Switching to our Cardiac Muscle Program, Amgen continue to work around the world to activate centers and enroll patients into GALACTIC-HF. The Phase 3 cardiovascular outcomes clinical trial of omecamtiv mecarbil. Currently start-up activities are well underway with regulatory approvals obtained in the great majority of countries where the trial will be conducted and it’s enrollment is planned. At our first investigators meeting at the American College of Cardiology or ACC last month we were pleased to see great enthusiasm for the trial among the investigators and we continue to hear statements regarding the urgent need for new approaches to treat patients with heart failure with systolic dysfunction from the podium during several scientific presentations. Also at ACC additional results from COSMIC-HF were presented in a poster by forbearing Sorenson from the Brigham Williams – Brigham & Women’s Hospital. The results represent the first direct echo cardiac graphic evidence in humans that increases in the contractility of cardiac muscle underlie the improvement in overall cardiac function observed in COSMIC-HF. Specifically, this analysis show that omecamtiv mecarbil improved miocardial deformation, which is a measure of miocardial contractility that has been positively related to cardiovascular outcomes. In addition to other results previously reported, these findings from COSMIC-HF represent another positive signal of improvement in cardiac function, potentially related to improved overall cardiovascular outcomes. We look forward to extending this finding in the second Phase 3 clinical trial we plan to conduct in parallel to GALACTIC-HF, which will examine the effect of omecamtiv mecarbil on exercise tolerance and cardiac function. This clinical trial will be conducted by Cytokinetics in collaboration with and primarily funded by Amgen. We are engaged in clinical trial planning activities and will have more to say about that trial later this year. Finally, we remain on track to report results of the ongoing Phase 2 clinical trial of omecamtiv mecarbil in Japan in Q3. This trial, which is mostly focused on safety and pharmacokinetics is expected to inform the potential for patient of Japanese investigational site in GALACTIC HF later this year. So with those updates, I’ll now turn the call over the Pete, to provide his update on our financials.

Thanks Roddy. As our press release contains detailed financial results for the first quarter of 2017, I’ll refer you to that public statement for the details on our P&L and balance sheet. I’ll touch here on our cash, some details regarding our revenues and our spending on R&D. Robert commented earlier that we added a $100 million list to our balance sheet during the first quarter from the Royalty Pharma transaction. That deal generated $90 million in cash and $10 million from the sale of common stock. We ended the quarter with $257.2 million in cash, cash equivalents and investments, which represents over 24 months of going-forward cash burn, based on our 2017 financial guidance. Revenues for the first quarter of 2017 were $4.2 million, compared to $8.4 million during the same period in 2016. These revenues included $1.4 million of license revenues and $2.7 million of research and development revenues from our collaboration with Astellas, $0.9 million from our collaboration with Amgen and $0.3 million in research and development revenues from our collaboration with the ALS Association. We paid Amgen $1.3 million out of the $40 million we will cofounded with Phase 3 development program of omecamtiv mecarbil. That $1.3 million payment offsets research and development revenue in the statement of operations. Revenues for the same period in 2016 were comprised of $4 million of license revenues and $3.7 million of research and development revenues from our collaboration with the Astellas. And $0.6 million of research and development revenues from our collaboration with Amgen. Our first quarter 2017 R&D expenditures totaled $19.3 million. From a program perspective for the first quarter, approximately 84% of our R&D expenses were attributable to our skeletal muscle contractility programs which include both expenses associated with tirasemtiv and CK-107, 12% to our cardiac muscle contractility program and 4% to other research activities. Finally, our G&A expenses incurred both traditional administrative expenses, as well as internal and outside services focused on commercial readiness. And with that I’ll turn the call back over to Robert.

Thank you Pete. I’d like to close with additional updates regarding our commercial readiness and research activities. During the quarter, we continued our readiness activities in preparation for positive data from VITALITY-ALS and potential filing approval in commercialization of tirasemtiv both in the U.S. and Europe. Firstly, we met with market access specialist representing Germany, France, Italy, Spain and UK to gain insights into the elements required in an orphan drug value proposition to support help technology assessments and potential payor reimbursement. Similarly, we continued market research with payor’s to benchmark reimbursement approaches to novel mechanism orphan therapeutics. We also conducted market research with patients to inform packaging decisions and recently initiated a process to secure distribution and potential early access partners. As you may imagine there are multiple work streams proceeding in parallel to ensure we are ready for commercial launch. Pending positive results in marketing authorizations. We’re also planning for success with CK-107 in adult an adolescent patients with FMA. While FMA treatment is rapidly changing, with the recent approval of Spinraza we believe there will still be a prevailing unmet need to improve muscle function, power and stamina in these patients. As such we’re conducting market research with patients payors and specially pharmacies to explored potential commercial formulation options for CK-107 in FMA. And as we prepare for commercialization of lead drug candidates, we are also have exciting research underway and we’re looking at potential next-generation muscle activator approaches in partnership with Amgen and Astellas as well as also independently. We anticipate having more to say about these ongoing research programs potentially proceeding towards development later in the year. In summary, our activities across the breadth of the company continue to advance well during the first quarter of 2017. We remain optimistic about our prospects for the balance of the year across our diverse portfolio of novel mechanism muscle biology directed drug candidates. As always, our focus continues to be on the patients who desperately need new therapies to treat their severe and devastating diseases of impaired muscle function and weakness. Now let me recap our expected milestones for the remainder of 2017. For tirasemtiv we expect results from VITALITY-ALS in the fourth quarter of 2017 and we expect to continue to enroll patients who complete VITALITY-ALS into vigor ALS or open label extension trial throughout 2017. For CK-107, we expect data from a Phase 2 clinical trial in patients with SMA. During the second half of 2017, we expect Astellas to continue enrolment in a Phase 2 clinical trial of CK-107 in patients with COPD. In 2017 we expect Astellas to begin a Phase 1b clinical trial of CK-107 in elderly patients with limited mobility during the second quarter. And we expect to begin a Phase 2 clinical trial of CK-107 in patients with ALS in midyear, 2017. For omecamtiv mecarbil we expect continued enrolment of patients with chronic heart failure in GALACTIC-HF our a Phase 3 clinical trial of omecamtiv mecarbil throughout 2017. And we expect data from a Phase 2 clinical trail of omecamtiv mecarbil in Japanese patients with chronic heart failure that to occur in Q3 2017. And lastly for pre-clinical research, we expect to continue our research activities under joint research programs with each of Amgen directed to the discovery of next-generation cardiac muscle activators and with Astellas directed to the discovery of next-generation skeletal muscle activators, as well as we expect advance our own propriety programs. And operator, with that, we now open to the call to questions.

[Operator Instruction] The first question will come from Jason Butler with JMP Securities. Please go ahead.

Good afternoon, Jason.

Hi, Robert, thanks for taking the questions. I have three, first one VITALITY, can you give us an update on what you’re seeing in the drop out rate relative to what you would planed and EMPOWER for. And then second two questions are on the upcoming CK-107 trials. First in ALS, I know you said you are going to give details later on trial design, but can we assume that the focus here will also be on respiratory measures. And then can you give us sense of what you would be measuring in the trial with elderly patients with limited mobility? Thank you.

Sure I’ll start – I’ll turn it over to Andy, and then also to Fady. With regards your first question, we haven’t commented on the early termination rate other than that, which we said occur during the open label period, which mirrored what we saw during the first two weeks of BENEFIT-ALS. So we’re pretty encouraged by that otherwise, we haven’t yet commented on that and we will do so after we have more of aggressive of the study through to last patient last visit. With respect to your second question CK-107 in ALS. Yes, I think your assumption is a good one, as we’ve stated already, this will be a study roughly the same timeframe duration as was the BENEFIT-ALS study and will be primarily focused on respiratory function in as much as we think over a shorter duration study like that. That’s the most sensitive measure of this mechanism of action and over longer periods of time, as we might then proceed in Phase 3 would be able to assess for other parameters of muscle strength and muscle function. So Andy, I’ll just turned to you, is anything more that you’d add to that.

I don’t think I would, no.

Okay. So that’s an answer I think two questions, one and two, and maybe I’ll turn it over to you Fady, for an answer to the questions three about the kinds of end points will look at with regard to elderly subjects with limited mobility.

Yes. So in that study will be looking at muscle strength and fatigue ability by certain repulsive leg extension. So, essentially looking at the amount of work that the patient can do in fatiguing exercise, but we’ll also be looking at other things such walking time, stair claim test and some scales of physical function that has been used in this population for quite some time.

Thanks, Fady. Thanks for taking the question.

Thank you.

You’re welcome.

The next question will come from Joe Pantginis with Rodman & Renshaw. Please go ahead.

Hi, Joe.

Hi guys, good afternoon. Thanks for taking the question. Two questions, first – Robert, first thanks for sharing your commercial activities that are going on in the background. I just wanted to maybe extent that a little bit and to see, if you discuss you’re manufacturing capacity and readiness for the initial market for tirasemtiv.

It’s a good question, we are increasingly going to be sharing updates on some of the things we are doing from the stand point of commercial readiness, as I think it’s especially important that investors know that we are preparing for success. Now I with respect to some of market access and market research I spoke to, but yes, also with regard to manufacturing. There are still certain things that we need to be doing that we haven’t yet done, but through the second half of this year we expect to be conducting those activities making those registration batches and having every thing up on stability. So that we could be enable to proceed through to potential NDA and MAA filings in the 2018 timeframe to support potential commercialization as would follow. I’ll turn to you Fady to see if there’s anything else you want to elaborate with regard to that.

I think just a main point I’ll make is that we’ve been manufacturing this scale that we were manufactured commercially to support our clinical trails. So the transition of commercial delivery of API would primarily be focused on just doing more of that is the same scale. But as Robert mentioned, we still have work to do there in order to get through the – what are the required regulatory steps for commercially beyond manufacture.

We are engaging with regulatory authorities regarding what should be expected from a conventional CMC type of dialogue at this stage. And we are trying to insure that we’re maximally ready, so we can proceed on the basis of potential positive data to VITALITY-ALS promptly in 2018. And again there are certain things we still need to do, but I think the good news is, this is a small molecule manufacturing and we’re looking at conventional cost of goods we’re looking at conventional scales with validated manufacturing parties, then we have quite ample experience and we’re preparing for what could be a standard set of filings and that regard.

Very, very helpful, thank you. And maybe just the quick follow-on, with regard to Japanese study with omecamtiv. As you mentioned as we know the – it’s the primary end point of safety and pharmacokinetics are the efficacy measures basically what were you seen and are used in COSMIC as well.

Yes, the other – you are doing act those in these patients, but one after recognize, it’s a much smaller studies in COSMIC. So we’re not powered to see the same kinds of changes that we saw in COSMIC. But we will be mostly looking for changes in the ejection time, which is almost sensitive measure.

Great. Thanks a lot guys.

Thank you.

The next question will come from Charles Duncan with Piper Jaffray. Please go ahead.

Hi, Charles.

Hi, Robert. First up all, congrats in the progress. Thanks for taking the questions. And just a couple one is going back to VITALITY-ALS. The recent DSM-V just trying to get – I’m just wondering if the DSM-V was just considering safety and what kind of observations, they were or events they are looking at. Or was there any type of efficacy or utility analysis. Is there anything that we can take away from that recent decision?

So they see all the data, and they see all of that in an unblended fashion. That is not formal interim analysis for either overwhelming success nor for utility, but they do have the ability do recommend for example that’s the study the terminated if they felt that needed to be for one of the two reasons. They just said and continue on.

Okay, and then going back to – I guess one of the earlier questions for dropout rates, it was make sense that when you went into the study you had have some believe that there’s going to be certain progression in these patients, I know that your doing a lot of work to sore that up within the clinical trial setting. Could you share with us your assumptions about your progression in patients generally and specifically those that might be in your trail and timeline?

When you say progression, you mean progression to milestones relating to their outcomes.

Yes.

The fact of the matter is with regard to conductive studies with ALS, we have a quite abundant data to look at where the baseline characteristics across many studies tend to be more alike then difference. And based on public data bases and placebo groups in those studies sadly the difference between the placebo group and the treatment group in those studies is not very notable given that historically so many things have failed in ALS, we can learn a lot about what to anticipate from the standpoint of progression of different assessments and mapped that into our planning and design for VITALITY-ALS, which we did. We are still blinded as you know with respect to who receive drug and who receive placebo. But I think it’s fair to say that we are seeing in the aggregate blinded data the kind of outcomes that we would expect to see for a study of this duration.

And if anything maybe your certain end point which could be meaningless or could be encouraging.

Okay. Obviously you are doing the experiment [indiscernible] a reason. So we’ll wait till that but that – until we get the actual data. But that’s helpful. Last question is regarding the standard of care for SMA I believe – mostly you were at AEN recently, clearly there is an evolving standard of care for SMA and lot of excitement about their program. What did you learn about SMA and at the recent AAN and how does that impact you’re think in terms of the target for your Phase 2.

Yes, good question. So both at the AAM but I’ll also comment one learnings from our attending a Cure SMA organized workshop a patient center drug development workshop with FDA that occurred in the week prior clearly we’re very impressed with uptake of Spinraza and it looks like it’s making a meaningful impact around the globe both patients who are paying for it and in the early access program in those other countries. But as we are learning it is still primarily being used in certain centers and for mostly type 1 infants and children. What we learned in particular at the Cure SMA organize meeting with FDA from investigators patients and care givers it remains still a very significant unmet need and interest with respect to potential drugs that would have a fracture muscle strength and alleviate some of dysfunction associated with muscle weakness. That was perhaps the most pronounced thing that we heard over-and-over from patient and care giver testimonies and I think the FDA heard that very loudly and clearly. That was echoed by comments we received at our investigators meeting at AAN and I think there is still a very profound need that we hope we may address with CK-107 as we’ll start to learn from this hypothesis generating study with CK-107 hopefully with results due later this year. So, we continue to believe that CK-107 would play a meaningful role along side of both Spinraza but also other approaches that are being perceived by AveXis and Roche and were none of those approaches would have the ability with this being an oral therapy to potentially impact muscle weakness the way we hope CK-107 will.

That’s helpful Robert, we continue to be compiled by the differentiate mechanism and you have the additional learnings from those other programs that how your program could be very different. So thanks for taking the questions.

You are welcome.

The next question will come from Ritu Baral from Cowen and Company. Please go ahead.

Hi, Ritu.

Hi, guys its Kevin on for Ritu. Could you discuss with respect to VITALITY-ALS, could you discuss what the effect of meeting the primary endpoint on SVC would have on other functions and clinical outcomes.

Certainly we can speculate about what might be correlations between vital capacity and other endpoints that we will be accessing also in this trail, obliviously that speculation given were still blind into the data. But maybe Andy I’ll turn it to you and in fact if you want to add afterwards.

Well I think if we can see a similar slowing and a decline in vital capacity that we didn’t benefit ALS but that continues for a much longer period of time, four times as long, because recall benefit ALS was 12 weeks long and VITALITY-ALS is 48 weeks long. Then I think there is opportunity to see what benefit ALS was too short to show and that is there may also be concurrence slowing of the decline of respiratory scores on the final three questions of the ALS functional rating scale that affects shortness of breath or dyspnea or tachypnea or the inability to lay flat and breath comfortably and respiratory insufficiency, which involves the institution of assisted ventilation from noninvasive to invasive. So those are all things that we are indenting to look at our secondary endpoints and one would imagine should be effected by slowing in the rate of decline of SVC and as we published actually and may have more to say about deep explorations later. When we looked at the placebo data from the EMPOWER Phase 3 study of dexpramipexole it is very clear that, those with a slower decline in vital capacity take longer to reach certain critical outcomes like the use of assisted ventilation.

Okay great. Thanks for taking my question. And congratulate on the progress.

Thank you. Thanks very much.

At this time there are no further questions.

Wonderful. Thank you, operator. And also thank you to all of our participants who joined us on the teleconference today. Thank you for your continued support and for your interest in Cytokinetics. Operate with that we can now conclude the call. Thanks very much.

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