Cytokinetics, Inc. Q1 2009 Earnings Call Transcript

Cytokinetics, Inc. (NASDAQ:CYTK)

Q1 2009 Earnings Call

April 30, 2009 4:30 pm ET


Robert Blum - President and CEO

Sharon Barbari - SVP of Finance and CFO

Andrew Wolff - SVP of Clinical Research and Development and CMO


Glenn Hanus - Needham & Company

Mark Monane - Needham & Company

Greg Wade - Webush Morgan

George Zavoico - Westport Capital


Good afternoon and welcome ladies and gentlemen to the Cytokinetics First Quarter 2009 Conference Call. (Operator Instructions).

I will now turn the call over to Sharon Barbari, Cytokinetics Senior Vice President of Finance and CFO. Please go ahead.

Sharon Barbari

Good afternoon and thank you for joining the Cytokinetics senior management team on this conference call to discuss our first quarter 2009 results. Also present during this call are Robert Blum, our President and Chief Executive Officer and Dr. Andrew Wolff, Senior Vice President of Clinical Research and Development and Chief Medical Officer.

Following the forward-looking statement disclaimer, Robert will provide an overview of the past quarter along with an update on the expansion of our pipeline focused to the biology of muscle function.

Andy will then provide highlights and details on the progress of the company's clinical development program.

I will then provide some brief comments with respect to our financials and our first quarter investments in ongoing research and development in light of the company's financial guidance for 2009.

Robert will then conclude the call with additional comments regarding recent activities and summarize our current progress in context of our projected company milestones for 2009. We will then open the call for brief question-and-answer session.

The following discussion, including our responses to questions, contains certain statements that constitute forward-looking statements for purposes of the Safe Harbor provisions under the Private Securities Litigation Reform Act of 1995. 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 materially differ from those in the forward-looking statements is contained in our SEC filings, including our most recent annual report on Form 10-K and 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 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 turn the call over to Robert.

Robert Blum

Thank you, Sharon. Cytokinetics began 2009 with a renewed focus and heightened sense of urgency and commitment that has already facilitated the achievement of three of our key milestones for the year.

First, during the most recent quarter, we delivered to Amgen what we believe to be the contractually agreed data that is intended to inform their option decision with respect to CK-1827452 or CK-452. We are pleased to have achieved this important objective and look forward to Amgen's decision.

Also, in the first quarter, we executed on two other meaningful deliverables. We presented the final results from CY-1121, a Phase IIa trial of CK-452 in stable heart failure patients at the American College of Cardiology meetings in March. Andy will have more to stay about these data in a moment.

Bottom line, we're pleased with the clinical performance to-date of this drug candidate and believe that the totality of the data from the completed five Phase I and two Phase IIa clinical trials support the advancement of CK-452 into Phase IIb clinical trials.

As you'll soon hear from Andy, we're now waiting for and anticipate initiating dosing in a Phase IIb trial of CK-452 mid-year.

In line with the theme of our 2009 annual report, defining our focus, we also continued to leverage what we have learned in the area of cardiac muscle contractility with the goal of expanding our pipeline in the area of the biology of muscle function.

Most notably, during the quarter, we have taken the steps to move ahead with our planned initiation in mid-2009 of a Phase I first-in-humans clinical trial of our fast skeletal muscle troponin activator, CK-2017357 or CK-357 in healthy volunteers in the United States.

Also, with regards to our skeletal muscle contractility program, we presented initial data at the 53rd Annual Meeting of the Biophysical Society and the 2009 Experimental Biology Conference.

All said, these milestones from the first quarter of 2009 positions us well as we look towards the remainder of the year. Of course, progress requires investment of capital, and as you will hear from Sharon, we believe we have taken the steps to prudently manage our financial resources, all the more important in these especially difficult economic times.

I believe we are suitably positioned to adapt to the current challenges of the financial markets with appropriately flexible operating plans and budget that permit us to dial up or dial back spending as may be warranted and as we endeavor to build increasing value for shareholders.

I would now like to turn the call over to Andy.

Andrew Wolff

Thank you, Robert. If you are familiar with our progress over the past several months, I think you may agree that we've delivered well against our clinical and nonclinical development objectives. This is best evidenced by the completion of a key Phase IIa clinical trial of CK-452 in patients with stable heart failure and the subsequent reporting of these data at the Annual American College of Cardiology Meeting last month.

In addition to moving our cardiovascular program forward, we plan to initiate treatment in a Phase I first-time-in-humans clinical trial of CK-357 in mid-2009. In March, at the Annual American College of Cardiology Meeting, we presented final data from our Phase IIa clinical trial of CK-452 in patients with stable heart failure.

To give you a greater sense of the rigor of this study, consider that these final results were derived from 45 patients among five cohorts who underwent a total of 151 separate treatment periods and from whom we obtained 564 echocardiograms.

Needless to say, this trial provided us with a richness of data that assists us in further defining the clinical potential of CK-452. The five cohorts included three separate dosing regimens, consisting of infusion periods of 2, 24 and 72 hours and targeted plasma concentrations ranging from 90 to 650 nanograms per ml.

The final results demonstrated that CK-452 increased systolic ejection time, stroke volume, cardiac output, fractional shortening, and ejection fraction, by either the hybrid or 2-D method in a plasma concentration dependent manner. Because decreases in ventricular volumes in response to treatment with other therapies have been associated with improved outcomes in heart failure, we were especially encouraged to observe decreases in both end-systolic and end-diastolic volumes with CK-452.

In contrast to beta-adrenergic agonist and phosphodiesterase inhibitors, which directly increased heart rate while increasing systolic function, the increases in systolic performance that we observed with CK-452 were associated with decreases in heart rate.

In addition, infusions of CK-452 appeared to be generally well tolerated in these stable heart failure patients over a range of plasma concentrations during continuous intravenous administration.

We also recently initiated an additional Phase IIa clinical trial of CK-452. This clinical trial is an open label, multi-center, multiple-dose trial designed to evaluate and compare the pharmacokinetics of both the modified and an immediate release oral formation of CK-452 in patients with stable heart failure.

The trial is currently planned to enroll three cohorts of between 6 and 12 patients each. Because this is an open label study, we plan to gather the pharmacokinetic data as each patient completes treatment.

We could conduct the upcoming Phase IIb trial of oral CK-452 in chronic heart failure outpatients at increased risk for death and re-hospitalization for heart failure with either the immediate or modified release oral formulation.

So, this Phase IIa study is intended to provide full pharmacokinetic profiling of each of these oral formations in heart failure patients in order to assist us in making our decision as to which formulation to study in the Phase IIb trial. In parallel with these activities, we're working to finalize the protocol for the Phase IIb trial.

Turning to our oncology program; we continue to advance the Phase I portions of the Phase I/II clinical trials for each of ispinesib and SB-743921 and SB-921 on a schedule of once every 14 days, which we believe has the potential to provide a greater dose density than the previously studied regimen of once every 21 days, while maintaining the excellent tolerability we have seen to-date with each of these compounds.

In addition, GlaxoSmithKline, or GSK, continues to enroll and dose-escalate patients in a Phase I first-in-humans clinical trial evaluating GSK-923295 or GSK-295 in patients with advanced, refractory solid tumors.

Interim results from this trial were presented during the quarter at the American Association of Cancer Research's Annual Meeting.

Lastly, as you heard from Robert, in mid-2009, we are preparing to initiate a Phase I first-in-humans clinical trial of our fast skeletal muscle troponin activator CK-357 in health volunteers in the United States.

The fact that we'll accomplish this in addition to all of the other development activities we're pursuing for CK-452, ispinesib and SB-921 is a real tribute to the effective collaboration of the nonclinical research and development regulatory affairs and clinical research and development teams at Cytokinetics. We will elaborate more on the design of this trial once we dose the first subject.

With that update on our clinical development programs for the first quarter, I'll turn the call back over to Sharon.

Sharon Barbari

Thank you, Andy. As our press release contained detailed financial information for the quarter ended March 31, 2009, let me refer you to that public statement, but also provide you with a little more detail on how our research and development or R&D spending is now aligned by program and our financial guidance for the year.

Our first quarter 2009 R&D expenditures totaled $10 million. From a program perspective, for the first quarter approximately 39% of our R&D expenses were attributable to our cardiac muscle contractility development and research activity, 26% to our skeletal muscle contractility research and preclinical development activities, 12% to our mitotic kinesin inhibitor development activities, and 21% to our research and nonclinical development activities which include our smooth muscle contractility program.

As of March 31, 2009, cash, cash equivalents and investments, excluding restricted cash and the put option on our auction rate securities, totaled $81.4 million, compared to $73.5 million at December 31, 2008.

The increasing cash and investments was primarily due to the receipt of loan proceeds of $12.4 million from UBS and $6.8 million net from our committed equity financing facility with Kingsbridge offset by cash used to fund our operations.

Given Amgen's potential exercise of its option for CK-452, we believe we are continuing to prudently manage the business in view of the uncertainty as to whether or not Amgen will exercise its option.

Cytokinetics is reiterating its previously stated guidance for 2009. We anticipate our 2009 net cash utilization to be in the range of $52 million to $57 million, with cash R&D expenses expected to be in the range of $38 million to $42 million and cash G&A expenses to be in the range of $14 million to $15 million.

While Amgen may choose to exercise its option for an exclusive license to develop and commercialize CK-452, there is no certainly that this will occur. Accordingly, this financial guidance excludes any revenues associated with such an option exercised by Amgen, including any projections regarding potential reimbursement of R&D expenses related to CK-452.

This guidance does not take into account revenues from other potential collaborations that Cytokinetics may enter into in 2009, relating to CK-452 or other programs. However, if Amgen does exercise its option, we will provide an update to our 2009 financial guidance taking into account the $50 million option exercise fee that Amgen would pay to us and any other payments that we may receive from Amgen for R&D activities related to CK-452 that we may conduct under Amgen's sponsorship.

Our financial guidance is on a cash basis and does not include an estimated $12.2 million in GAAP revenues related to Amgen's initial payment for its option for a license to CK-452 and $7.5 million in non-cash related operating expenses primarily related to FAS 123(NYSE:R) stock compensation expense.

That concludes the financial portion of today's call. With that, I'll turn the call back over to Robert.

Robert Blum

Thank you, Sharon. As you can see, we have been diligently attending to our financial resources, at the same time we continue to make progress in executing against our 2009 objectives.

Prior to concluding our prepared statements, I would like to comment on a few recent quarterly events that align nicely with our corporate strategy and identify what we see as our key milestones for the remainder of 2009.

To be clear, we are pleased with the results from our CK-452 clinical trials program and continue to believe that the data generated to-date support the therapeutic hypothesis for CK-452.

While we recognized the risk still ahead of us with CK-452, which is still in the middle stages of clinical development, we believe that data from our Phase I and Phase IIa clinical trials have produced ample and sufficient evidence to support the progression of this program into Phase IIb clinical trials.

Furthermore, at a meeting held in parallel with the ACC Annual Meeting in Orlando, we presented the final data from our CY-1121 clinical trial in stable heart failure patients to our clinical advisors.

While I cannot share the particulars of who was there, if you were to draw a circle around the most well respected opinion leaders in heart failure, chances are it would include many of those with us at that meeting.

These key advisors, several of whom are also our clinical investigators, continued to be encouraged with the performance of our novel drug candidate. They are very engaged in the design of future clinical studies and have expressed a broad interest in participating in their implementation.

In February, we delivered to Amgen the date from the Phase I and Phase IIA trials conducted with CK-452 that are intended to inform Amgen's exercise of its option to acquire an exclusive license to CK-452 worldwide, excluding Japan.

I'm pleased with the speed and thoroughness with which our internal teams executed on this important milestone. This delivery in February initiated the start of a time period, the duration of which we have not disclosed in which Amgen must now make a decision.

We are actively engaged with Amgen in answering their questions, while concurrently readying ourselves for the initiation of the Phase IIb clinical program. We intend to advance into a Phase IIb program of CK-452 with or without Amgen.

Of course, we hope Amgen will exercise its option, but we also must plan and budget for the conduct of Phase II development, even if Amgen were not to proceed as our partner for this program.

If you have not had a chance to review our 2009 annual report, I invite you to visit our website where an electronic copy is available. I say this as both the letter to our stockholders and the report itself clearly speak to a new focus at Cytokinetics and the evolution of our pipeline, as we continue to leverage what we've learned from the research and development of CK-452.

I'm optimistic about where we stand today and look forward to potential developments relating to our other muscle contractility related programs. The next significant step forward coming in the form of our planned initiation of a Phase I first-in-humans clinical trial for our fast skeletal muscle troponin activator CK-357. This is planned to occur in mid-year 2009.

On the corporate front, during the quarter, we appointed Dr. John Henderson to the company's board of directors. John brings over 30 years of experience in the life sciences industry, principally at Pfizer and with specific expertise in worldwide clinical development and medical affairs.

We are very pleased that he has joined our board and can lend his depth of expertise to our company's next stage of maturation. In addition, we named current director Stephen Dow as the company's Lead Outside Director.

Steve has been a member of our board of directors since 1998, and brings to this role a wealth of knowledge about Cytokinetics, but also accompanies moving from adolescence towards commercialization.

I believe it speaks volumes when a longstanding investor and board member chooses to increase his involvement after so much time previously devoted to the company. We are grateful for Steve's commitment to our business.

As we continue to strive to build our business in 2009, I would now like to share with you our key milestones. On the cardiovascular side of our business, we plan to present data from our Phase IIa clinical trial of CK-452 in stable heart failure patients as a late-breaking trial at the 2009 Heart Failure Congress of the European Society of Cardiology in Nice, France.

Additional echocardiographic data from the trial also will be presented in a separate poster session at that same meeting. Also at the 2009, ESC Heart Failure Congress, we plan to present data from our Phase IIa clinical trial of CK-452 in patients with ischemic cardiomyopathy and angina.

We announced top line data from this trial by press release in December of 2008. In mid-2009, we planned to initiate a Phase IIb clinical trial of oral CK-452 and chronic heart failure patients at increased risk for death and re-hospitalization for heart failure.

It should be noted that if Amgen were to exercise its option to CK-452, they would then control the timing and design of development activities for this program.

With respect to our oncology drug candidates, we plan to present data from the Phase I portion of the ongoing Phase I/II clinical trial of ispinesib administered as monotherapy as a first-line treatment in chemotherapy naïve patients with locally advanced or metastatic breast cancer at the Annual Meeting of the American Society of Clinical Oncology or ASCO in Orlando, Florida.

We also plan to present data from the Phase I portion of the ongoing Phase I/II clinical trial of SB-921 in patients with Hodgkin or non-Hodgkin lymphoma also at ASCO. In addition, we anticipate that GSK will present data from the Phase I clinical trial evaluating GSK-295 in patients with advanced, refractory solid tumors also at ASCO. GSK has informed us, they anticipate initiating a Phase II clinical trial of GSK-295 in 2010.

Looking to our other ongoing development programs in mid-2009, we plan to initiate a Phase I first-in-humans clinical trial of CK-357 in healthy volunteers in the United States. In 2009, we also plan to progress our smooth muscle myosin inhibitor in IND-enabling studies.

To summarize and conclude, I'm pleased with Cytokinetics performance during the quarter and believe that we executed well. While we are very aware of the challenges the external environment is presenting, I believe our commitment to focus primarily on the biology of muscle function, while also acting as good stewards of shareholder's capital, will enable us to develop a company with a pipeline of novel drug candidates, any one of which, if approved and commercialized, could be transformative for our business prospects.

That now concludes the formal portion of our call today. With that, I'd like to open up the call to questions.

Question-and-Answer Session


(Operator Instructions). Your first question comes from Mark Monane of Needham & Company.

Glenn Hanus - Needham & Company

Hi. This is Glenn answering for Mark. My first question is on the recently initiated Phase IIa trial for multiple dosing for intermediate and oral for the PK. How long will that trial take and what are the goals that will inform the upcoming Phase II for the outpatients?

Robert Blum

So let me start and then I'll turn it over to Andy. This, while termed a Phase IIa trial, also can be viewed as a bridging study, and as such, it should not be expected to take a long time. I'll now turn to Andy to tell you how it informs our Phase IIb study.

Andrew Wolff

So as I mentioned during the call, we could conduct the Phase IIb study using either the immediate release or the modified release formulation of oral CK-452. This trial will give us formal pharmacokinetic data in heart failure patients from both of those formulations. We already have a pharmacokinetic evaluation of each of them in healthy volunteers.

So, we think we can pretty accurately predict what the data will show, but this is confirmatory. It's already begun to enroll relatively quickly. So, I'm not anticipating that it will take too long to complete.

Robert Blum

Nor do we anticipate that for the conduct of this study, it will introduce a delay to our planned initiation of the Phase IIb clinical trial intended for mid-year.

Glenn Hanus - Needham & Company

Thank you very much. I have a question on the muscle skeletal activator program, which I think is quite exciting. In patients who have weaknesses from diseases, such as muscular dystrophy, the cause could be variable, many causes of the subtypes of the disease.

How does the company feel that the muscle skeletal activator will be used in diverse disease? Or will there be specific disease that this type of therapy would be more favorably directed?

Robert Blum

So again I'll start and then ask Andy if he wants to elaborate. We are right now in the process of prioritizing those Phase II diseases, indications, syndromes, and conditions around which we would proceed forward. And there are, as you point out, a diversity of places where a fast skeletal muscle activator such as this could be useful.

I'd say it's premature for us to go into this in too much detail until we've had a chance first to initiate dosing in healthy subjects in Phase I. And as then we'll proceed through the course of the year, we expect we'll have an R&D day and we can then elaborate much more on what we know from preclinical evaluation and also where that may read on opportunities here.

Andrew Wolff

So maybe what I'll add is to say while based on an understanding of the compounds mechanism, it could be useful across a broader array of syndromes and conditions that involve muscle weaknesses. From a development perspective, we will have to focus on specific well-defined patient populations for whom we can show clinical benefit.

It could be that there will eventually be a multiplicity of such indications, but we'll start probably with the one that we evaluate to be most tractable for us. Then as we may be able to get the drug approved, expand into markets that may be larger, but perhaps more difficult, involve a more difficulty development pathway and I think that's probably where I should leave it at about now.

Glenn Hanus - Needham & Company

Well, thank you very much for the added color. I just have one last financial question is that you spoke about dialing up and down research spend based on your various options. Could you give us more color on that and how you achieve that?

Sharon Barbari

Yes. I think that the thing that we have done internally is, we've really prioritized the various different projects that we have. Obviously, 452 is the most important project to us. So, we internally have determined which projects and at what rate of speed we could continue to develop each of them and if we needed to dial up spending on 452, that we could do that and we would back away from some of the earlier research programs and just move them on a slower timeline.

Glenn Hanus - Needham & Company

Thank you very much. Mark Monane has one question.

Mark Monane - Needham & Company

Thanks. Good afternoon. I just have one big picture question. When we were, I think when Andy and I were in medical school we were told not to give beta blockers to patients wit heard failure that it was contraindicated, it was even a board question. Now, we are seeing increased attention to beta blockers and indeed there are some beta blocker that's are being developed and under regulatory review.

Can talk about the use of 452 in a patient on a beta blocker, maybe that patient has diastolic dysfunction, maybe not, maybe here she is or on the drug for antiarrhythmic potential. Can you talk about that, please?

Andrew Wolff

As I'm sure, Mark, beta blockers are actually indicated in patients with systolic dysfunction and symptoms of heart failure now and it is a rather ironic term because you're right, when we were kids, there were imagined to be contraindicated, but now we know that the diminished sympathetic input to the muscle that occurs in the presence of beta blockade carries with it many beneficial effects over time.

Actually, almost all, and I think all actually, I would have to check, of the patients that we've treated in our Phase IIa study so far have been on a beta blocker because it's standard-of-care. The protocols did contain language that allowed them not to be on beta blockers, if they were demonstrated not to tolerate them. But without having the tables close at hand, I don't think there was any one of them that actually was not receiving a beta blocker during the trial.

We know from preclinical data that the affect of the compound to improve cardiac contractility can be observed even in the presence of a beta blocker, the way in which the compound operates actually is separate from the pathway that both beta blockers and beta agonist impinge upon to have their differing affects on muscle function.

So having a beta blocker in place does not by any means prevent the effect of 452 from being observed, because indeed, as I've already pointed out, all of the data that we presented to-date on improvements in systolic function in heart failure patients from the study CY-1121 in stable heart failure patients essentially is in the presence of beta blockade.


Your next question comes from the Michael Aberman of Credit Suisse.

Unidentified Analyst

Actually, it's [Ying] in place of Michael, because Michael is traveling. My two questions have to do with the Phase II study as well. First question is, would you be able to conclude this study in time so that the data can be presented to Amgen to inform their physicians?

And the second question is, would you also collect anything such as pharmacokinetic data or cardiac function (inaudible).

Robert Blum

So let me take the first one and I'll turn to Andy for the second one. This is a study that has begun and was recently initiated after we delivered the data required to inform Amgen's decision.

So, as such, it is not required and we are proceeding forward with the expectation that Amgen will makes its decision independent of receipt of any of these data as to what might be the pharmacodynamic measures, I'll turn to Andy.

Andrew Wolff

This is really, strictly a pharmacokinetic study. It is mainly to evaluate the plasma levels generated in heart failure patients by these two different oral formulations and we're not obtaining echocardiograms or anything else on treatment in the study. We just need to look at the plasma levels.


Your next question comes from Greg Wade of Webush Morgan.

Greg Wade - Webush Morgan

I was wondering if you could just characterize the discussions that you've had with the Amgen folks subsequent to delivering the data to inform their option?

Robert Blum

So we have a regular, I'd say, near daily conversation with Amgen on a host of matters relating not only to the data we delivered as it may pertain to questions regarding our conclusions or analysis in light of that data, but also a number of other things. We talk about things that fall out side of what is required contractually in order to inform their decision.

As we've spoken publicly, we have engaged with Amgen together with our consultants on the interpretation of current data and also planned next-stage trials. We have also engaged with Amgen on matters relating to manufacturing preclinical, but also other commercial planning, all with an idea on I think where Amgen too exercise we'd be in a really good place together in terms of alignment and mindset on how we might proceed forward.

Because as you know, if they do exercise, we would proceed forward under a joint development program and plan and we would have opportunities to share in the conduct of that plan. So all of those conversations continue even as we recognized Amgen is considering whether or not they will exercise.

Greg Wade - Webush Morgan

With respect to when this period of time could conclude that they're afforded the option to continue to try to phone you and chat about these things, what are the firm conclusion points that this time period can conclude? That would be just fine.

Robert Blum

I don't think I can say anything more than I've already said about that, which is they have a defined period of time under which they must make their decision. What we have also said is that as we may initiate Phase IIb that would render their option no longer exercisable.

Greg Wade - Webush Morgan

Do you anticipate based on your present plans that the Phase IIb start would be ahead of the hard stop defined in the contractor or vice versa?

Robert Blum

I really can't say. It's a good question, though.

Greg Wade - Webush Morgan

Well, you know when you're going to start Phase IIb?

Robert Blum


Greg Wade - Webush Morgan

And you know what the hard stop date is?

Robert Blum

Right. But I don't think I can answer your question for fear that that would put me also in a position of disclosing something that is deemed confidential here.

Greg Wade - Webush Morgan

Okay. My next question is with respect to the 357, Andy, I was wondering if you could help us to better understand from your in vivo models what the limiting affects are in animals?

Andrew Wolff

In animals, given excessive doses of the drug, they become stiff and they actually cannot move as much freely as before.

Greg Wade - Webush Morgan

But all other sort of excretory and regular body functions are maintained?

Andrew Wolff

It's an on target affect which, as I said many times before, any time the dose limiting affect of a drug is related to its intended mechanism, that is always a good thing. So we do not see off-target affects.

Greg Wade - Webush Morgan

And then just lastly, if we can circle back to the plans going forward. So if Amgen does not step up, does this mean 357 development will be delayed?

Robert Blum

That's a very good question. That's one of the things that we're considering when we talk about what we would dial up or dial back. Our hope is that we would be proceeding forward with 357 and other things might be delayed but ultimately, it will depend on where we sit financially and how we think about, what would then be the remainder of the year. I don't expect that will have affect to the timing of the start of Phase I, but it might have affect to the conduct of Phase II.


Your next question comes from George Zavoico of Westport Capital.

George Zavoico - Westport Capital

Quick question for Andy regarding the PK study. I think I know the answer. Is there any reason to expect there might be a change in pharmacokinetics from heart failure patients relative to the healthy volunteers?

Robert Blum

It's always a possibility, but I can tell you with the IV, the pharmacokinetics' healthy volunteers have predicted the PK in our stable heart failure population extremely well, but now we're dealing with oral absorption .So in theory, there could be a difference between volunteers in heart failure patients and that would be one reason to take a look at the data.

George Zavoico - Westport Capital

Now was the cardiac catheterization study, in the press release you announced that you continue to screen patients for potential enrollment. Is there anything more you can say beyond that, whether you've enrolled patients, how many you've enrolled and how that trial is progressing?

Robert Blum

So what we have said is it's not progressing very quickly. This is one of those things where also we have purposefully not lit a fire under that study in order to be able to be in a best position to conserve capital. It's a study that, as you know, has some value, certainly would be nice to have the results of that study as they may speak to recapitulation of data that we saw preclinically that lend a differentiation to CK-452 relative to [on the strokes].

But in as much as that's a study that wasn't critical path and high priority in this calendar year, it has not been on the front burner. And apart from that if terms of how many patient have been enrolled and when we might have data, I think I would prefer not to speak to that until such time as we've gotten more, let's say, area under the curve in terms of patients enrolled.

George Zavoico - Westport Capital

That's understandable, but remind me. Did you increase the number of sites that are doing them?

Robert Blum


George Zavoico - Westport Capital

Yes, you did. Okay. Finally, a financial question. Relative to the last quarter, you guys have been really quite impressive in the R&D. Despite all of the extra stuff that you're doing, it looks like you decreased your R&D spend from the fourth quarter last year. On the other hand, G&A has gone up. Can you just briefly speak to how fast?

Sharon Barbari

Yes. From a R&D perspective, I just think that you have to look at R&D as probably a lot more variable depending on the program where G&A expenses are more fixed. There are lot of costs associated with being a public company, so they're a little less variable. Some of that is timing too.

Obviously, it includes legal expenses, patent expenses, accounting fees, those types of things when you move quarter-to-quarter. So some of those tend to be a little bit more front-loaded in the beginning of the calendar year as you're going through your year-end audit and those type of functions.

Robert Blum

Sharon, is it also fair to say that as it relates to comparing a first quarter to fourth quarter in terms of ready spending; the fourth quarter reflected the fact that we did a restructuring at the end of the third quarter but also had to pay out restructuring related costs in the fourth quarter and the first quarter of that was less the case.

Sharon Barbari

Most of the costs related to the restructuring were incurred in the third quarter.

Robert Blum

In the third quarter, okay. So forget what I said.

Sharon Barbari

But we were winding down programs in that fourth quarter.

Robert Blum

Does that help, George?

Sharon Barbari

And those savings are just better realized in the first quarter then.

Robert Blum

That's correct.

Sharon Barbari


George Zavoico - Westport Capital

Thank you very much.


There are no further questions at this time. Mr. Blum, I hand the call over to you for closing remarks.

Robert Blum

Okay. Thank you, Operator. We're certainly grateful for the interest that everyone has in the ongoing activities of Cytokinetics. We look forward to updating you with our next earnings call. With that, we should now end this call. Thank you.


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

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