Cytokinetics, Incorporated (CYTK)

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Cytokinetics, Incorporated (CYTK)

Q4 2013 Earnings Conference Call

February 06, 2014 04:30 PM ET


Sharon Barbari - EVP, Finance and CFO

Robert Blum - President and CEO

Dr. Andrew Wolff - SVP, Clinical R&D and Chief Medical Officer

Dr. Fady Malik - SVP, Research and Early Development


Ritu Baral - Canaccord

Simos Simeonidis - Cowen & Company

Jason Butler - JMP Securities

Paul Matteis - Leerink Swann



Good afternoon and welcome ladies and gentlemen to Cytokinetics Fourth 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 question-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 remarks 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 for the potential treatment of ALS and also will provide an update on the Phase I clinical trials of CK-2127107 or CK-107 in healthy volunteers. Next Dr. Fady Malik, our Senior Vice President of Research and Early Development will update you regarding recent progress in clinical development of omecamtiv mecarbil for the potential treatment of heart failure.

I’ll then provide a financial overview for the quarter. Robert will then conclude the call with additional comments regarding how the company activities align with our corporate strategy and projected milestones for 2014. We will then open the call for questions. Please note the following discussion including our responses to questions contains 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.

I’ll now turn the call over to Robert.

Robert Blum

Thank you and good afternoon. Thanks to everyone on the line for joining us on this call today. 2013 was a successful for Cytokinetics. In 2013, Cytokinetics delivered on key objectives in research and development and in other areas relating to business development and overall across the company. Taking all together our company’s solid execution in 2013 now positions us well in 2014. In R&D we progressed each of our clinical development programs to important milestones, that progress was accompanied by our new alliance with Astellas and our expanded strategic alliance with Amgen.

I am proud of the progress Cytokinetics made last year. Looking forward we’re focused to the continued development of our three clinical stage programs as well as further corporate development initiatives that we expect can position the company to deliver on our mission in the results and potential returns for all our stakeholders.

Starting with a look at the progress made during 2013 and our skeletal muscle contractility program. In the fourth quarter we completed the enrollment of BENEFIT-ALS with 711 patients. We’re now focused to the completion of the trial and look forward to the potential presentation of results from BENEFIT-ALS in April at the Annual Meeting of the American Academy of Neurology. This large international Phase IIb clinical trial tirasemtiv is designed to inform our global registration plans for this promising drug candidate and we’re evaluating strategic scenarios for the further development and the potential commercialization of tirasemtiv.

In addition, in 2013 we made progress under our new collaboration with Astellas for the development of CK-2127107 or CK-107 and in a conduct of joint research to identify next generation skeletal sarcomere activators. During the last quarter, we reported results from our first time in humans Phase I clinical trial CY 5011 as Andy will elaborate in a moment. More recently, we completed dosing in another Phase I trial CY 5014 evaluating the relative bioavailability of two different liquid oral forms as CK-107.

Both of these trials are part of an agreed development plan with Astellas that is focused to the characterization of CK-107 for potential evaluation as a treatment for non-neuromuscular diseases in Phase II trials. In our cardiac muscle contractility program, together with Amgen in the last quarter we prepared for the continuation of COSMIC-HF and progression of this ongoing Phase II clinical trial of oral omecamtiv mecarbil to the expansion phase.

We recently reported on changes to the trial design of COSMIC-HF that are included in the protocol amendment agreed with Amgen. We believe that implementing these changes in COSMIC-HF enables us to evaluate a plasma concentration guided dose titration strategy in Phase II that we anticipate implementing in the potential Phase III development of omecamtiv mecarbil and that may better reflect real world clinical practice.

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