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Cytokinetics, Inc. (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.
Previous Statements by CYTK
» Cytokinetics, Inc. Q4 2008 Earnings Call Transcript
» Cytokinetics Inc., Business Update Call Transcript
» Cytokinetics Q3 2007 Earnings Call Transcript
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.
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.
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.