Cytokinetics, Inc (
Q3 2010 Earnings Call
October 28, 2010 04:30 pm ET
Sharon Barbari - EVP, Finance & CFO
Robert Blum - President & CEO
Andrew Wolff - SVP, Clinical Research and Development, & CMO
Joel Sendek - Lazard Capital Market
Charles Duncan - JMP Securities
Ritu Baral - Canaccord
Mark Monane - Needham
Greg Wade - Wedbush
Larry Smith - DLS Research
Previous Statements by CYTK
» Cytokinetics Inc. Q2 2010 Earnings Call Transcript
» Cytokinetics Inc. Q1 2010 Earnings Call Transcript
» Cytokinetics Inc. Q4 2009 Earnings Call Transcript
» Cytokinetics, Inc. Q1 2009 Earnings Call Transcript
Good afternoon and welcome ladies and gentlemen to the Cytokinetics Third Quarter 2010 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 request of the company we'll open the call for question and answers after the presentation.
I will now turn the conference 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 today. Also present during this call are Robert Blum, our President and Chief Executive Officer and after 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 advancement of our development pipeline focused on the biology of muscle function. Andy will then provide highlights and details on the progress of the company's clinical development program. And then I will provide some brief comments with respect to our financials and our investments and research and development activity.
Robert will then conclude the call with additional comments regarding our recent activities and discuss the projected company milestones for remainder of 2010. We will then open the call for a 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 of the Private Securities Litigation Reform Act of 1995. Including but not limited to statements relating to our financial guidance, the initiation enrolment, design, conduct and result of clinical trial 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 the forward-looking statements is contained in our SEC filings, including our most recent quarterly report on Form 10-Q and our current reports on Form 8-K.
Copies of these documents maybe 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 will turn the call over to Robert.
Thank you Sharon, during the third quarter Cytokinetics continue to advance our pipeline focused to the biology of muscle function. In recent weeks we have conducted reviews of interim data from each of our two Phase IIa “Evidence of Effect clinical trials of CK-2017357 or CK-357. One in patients with Amyotrophic Lateral Sclerosis or ALS and the other in patients with symptoms of claudication associated with peripheral artery disease.
We are pleased with the progression of our skeletal muscle program. Moreover we are pleased with the interim results relating to the potential tolerability and also pharmacodynamic effects of CK-357 that are now emerging from these two ongoing trials. In a moment Andy will elaborate on our conduct of interim reviews of data for each of these trials. In addition during the quarter we are ready for the initiation of an Evidence of Effect trial in patients with Myasthenia Gravis which is still further evidence of our commitment to investigating the potential of skeletal muscle activates and in patients afflicted with neuromuscular diseases.
Also during the last quarter we announced that Amgen and Cytokinetics have reprioritized the order of planned clinical trials to relating to omecamtiv mecarbil, our novel cardiac myosin activator under joint development for the potential treatment of heart failure.
Together with our partner Amgen, we now plan to initiate a Phase IIb clinical trial of an intravenous formulation of omecamtiv mecarbil in hospitalized patients with acutely decompensated heart failure prior to initiating further clinical trials on oral formulations of omecamtiv mecarbil. This plan which is subject to a further discussions with regulatory authorities is intended to align feedback received from regulatory authorities and is designed to provide a larger placebo controlled experience with omecamtiv mecarbil prior to preceding to clinical trials of oral formulations over omecamtiv mecarbil in outpatients.
I would now like to turn the call over to Andy to elaborate on specific clinical progress achieved during the last quarter in our respective drug development programs and also to provide some insights into our plans for the future.
Thank you, Robert. As Robert just indicated, during the quarter our clinical team was highly involved with multiple activities related to our ongoing and planned clinical trials. We continue to in our rotations in our two ongoing Phase IIa Evidence of Effect clinical trial. The most advanced of which is our trial on patients with ALS.
To remind you, the primary objective of this early Phase IIa hypothesis generating trial is to evaluate the pharmacodynamic effects of CK-357 on multiple measures of skeletal muscle function or fatigability in patients with ALS at single dozes of each of 250 and 500 milligrams without specifying a single primary endpoint.