Cytokinetics, Inc. (CYTK)
Q4 2008 Earnings Call Transcript
February 10, 2009 4:30 pm ET
Sharon Barbari – SVP, Finance and CFO
Robert Blum – President and CEO
Andrew Wolff – SVP, Clinical Research and Development, and Chief Medical Officer
Mark Monane – Needham
Michael Aberman – Credit Suisse
Christopher James – Rodman & Renshaw
Charles Duncan – JMP Securities
Ching Chan [ph] – RBC Capital Markets
George Zavoico – Westport Capital
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I will now turn the call over to Sharon Barbari, Cytokinetics' Senior Vice President of Finance and CFO. Please go ahead.
Good afternoon and thank you for joining the Cytokinetics senior management team on this conference call to discuss our fourth quarter and year end 2008 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. Andy will then provide highlights and details on the progress of the company's clinical development program, and I will provide some brief comments regarding our investment in research and development in 2008 and the company's financial guidance for 2009. Robert will then discuss recent additions to the company’s pipeline and finish with a summary of our projected company milestones for 2009. We will then open the call for a brief question-and-answer session.
The following discussion, including our responses to questions, contain certain statements that constitute forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. Examples of such statements include, but are not limited to statements regarding our financial guidance for 2009, the expected focus, conduct, initiation, design, timing, scope, enrollment, progress and completion of our and our partners' research and development activities, the results from such activities, including the timing of availability and planned presentations of data from our development activity, and the possible significance of such results, the anticipated benefits of our muscle biology focus, our provision of data to Amgen to inform its potential exercise of its option, the potential receipt of funds under our strategic alliance with Amgen, potential partnering activities and the availability of funds under our committed equity financing facility and the properties and potential benefits of our drug candidates and potential drug candidates.
These statements involve a number of risks and uncertainties that are affected by a variety of factors and could cause actual results and the timing of events to differ materially from those anticipated by these statements. 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.
For a more detailed description of the risk factors that may affect our results, please refer to our SEC filings, including our most recent quarterly report on Form 10-Q. Copies of these documents may be obtained from the SEC or by visiting the Investor Relations section of our Website.
Now, I'll turn the call over to Robert.
Thank you, Sharon.
The past year was marked by significant progress we made in further defining the therapeutic potential of our lead drug candidate CK-1827452 or CK-452. Complementing our clinical activities, we expanded our muscle biology focus development pipeline with the advancement of one potential drug candidate in IND enabling studies and the addition of two other potential drug candidates into preclinical development.
As evidenced by the announcements in the fourth quarter, our clinical data from the phase I and phase IIa clinical trials, CK-452 continues to be a major focus for the company. Data from this drug development program continues to drive an increasing level of interest amongst investigators, and as Andy will share with you momentarily, we are encouraged with the top line data from the recently completed phase IIa clinical trial in patients with ischaemic cardiomyopathy and angina.
In addition, we're looking forward to the completion of our ongoing phase IIa clinical trial of CK-452 in stable heart failure patients. The latest interim data from this trial were presented at the American Heart Association meeting in November 2008, and we recently completed dosing in the fifth cohort of this trial. We look forward to the completion of final data collection and analysis for this trial in this quarter. Also in this quarter, we look forward to our delivery of the final clinical trials data to Amgen, which will in turn commence the period in which they may decide whether to exercise their option for a license to develop and commercialize CK-452 worldwide, excluding Japan.
As I mentioned earlier and will outline for you in greater detail later in the call, we recently announced the advancement of promising potential drug candidates from research activities focused towards muscle biology and more specifically the modulation of muscle contractility. As I believe you will hear on a call today, we continue to make important advancements in both our clinical, non-clinical and research pipeline in the past quarter, and indeed throughout the year, and we're looking forward to more of the same in 2009.