Cytokinetics, Incorporated (CYTK)

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Cytokinetics, Inc. (CYTK)

Q3 2013 Earnings Call

October 30, 2013 4:30 PM ET


Sharon Barbari – EVP, Finance and CFO

Robert Blum – President and CEO

Fady Malik – SVP, Research and Early Development

Andrew Wolff – SVP, Clinical Research and Development, and Chief Medical Officer


Simos Simeonidis – Cowen and Company

Charles Duncan – Piper Jaffray

Paul Matteis – Leerink Swann, LLC

Chad Messer – Needham & Company

Jason Butler – JMP Securities



Good afternoon and welcome ladies and gentlemen to Cytokinetics third 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 company’s request we will open the call for questions-and-answers after the presentation.

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

Sharon Barbari

Good afternoon and thank you for joining us on this conference call today. Leading today’s call is Robert Blum, our President and Chief Executive Officer. After Roberts opening comments Dr. Fady Malik, our Senior Vice President of Research and Early Development will update you regarding recent progress in the clinical development of omecamtiv mecarbil for the potential treatment of heart failure.

Next Dr. Andrew Wolff, our Senior Vice President of Clinical Research and Development and Chief Medical Officer will provide an update on the clinical development of tirasemtiv in patients with atrophic lateral sclerosis or ALS and also will provide an update on the Phase I clinical trial for CK-2127107 or CK-107 in healthy volunteers. I’ll then provide a financial overview for the quarter. Robert will then conclude the call with additional comments regarding how these recent activities come together to align with our corporate strategy and projected milestones for the remainder of 2013. We will then open the call for questions.

Please note that 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 Reform Act of 1995, including but not limited to statements relating to our financial guidance, and collaborations with Amgen and Astellas, to the initiation, enrolment, 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 may be obtained from the SEC or by visiting the Investor Relations section of our website. These forward-looking statements speak only as of today. You should not rely on them as representing our views in the future. We undertake no obligation to update these statements after this call.

Now I’ll turn the call over to Robert.

Robert Blum

Thank you, Sharon. And thank you to everyone on the line for joining us for this call today. We had a productive quarter and made important progress. I’ll start by giving a brief overview of the third quarter developments before than asking each of Fady and Andy to elaborate on the specifics of clinical development progress for each of our programs and then asking Sharon to put this all into the context of a financial overview.

Our focus continues to be on advancing our development stage drug candidates that have arisen from each of our cardiac and skeletal muscle programs, to complete comprehensive Phase II development programs before then potentially proceeding in later stage clinical development. Consistent with our stated plans we continue to execute on those major priorities and we had another very positive quarter.

In 2014 we expect to have the key data that will materially inform our plans. Starting with our cardiac muscle contractility program with presentations of results from ATOMIC-AHF at the ESC conference and additional analyses from this clinical trial presented a few weeks later at this HSFA conference we were pleased with the encouraging feedback we received from a wide cross section of the cardiology community who expressed enthusiasm for omecamtiv mecarbil in this Phase II B clinical trial.

In particular expert clinicians who reviewed the results support the continued development of omecamtiv mecarbil for the treatment of heart failure. Fady will provide commentary regarding conclusions from ATOMIC-AHF and he will also provide an update on COSMIC-HF in patients with chronic heart failure. We anticipate that the outcome of the COSMIC-HF trial along with the data from ATOMIC-AHF will inform final decisions regarding the progression of omecamtiv mecarbil into Phase III development for the potential treatment of heart failure. In the mean time we continue to prepare for that possibility and to dial up our activities in expectations of those decisions.

Moving towards skeletal muscle contractility program and in particular our activities in support of tirasemtiv with focus to the BENEFIT ALS trial we are now nearing in completion of enrollment in that trial. I am pleased to report that over 600 have been enrolled in BENEFIT-ALS and over 300 patients have completed 12 weeks of treatment. This large international Phase IIb trial is designed to inform our global registration plans and we are now preparing for multiple scenarios that we see as real possibilities for 2014 in order to capitalize on potential positive clinical results.

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