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Cytokinetics Inc. (CYTK)
Q1 2010 Earnings Call Transcript
April 29, 2010 4:30 pm ET
Sharon Barbari – EVP, Finance and CFO
Robert Blum – President and CEO
Andrew Wolff – SVP, Clinical R&D and Chief Medical Officer
Brian Wong – Needham & Company
Charles Duncan – JMP Securities
Yin Huang – Credit Suisse
Ritu Baral – Canaccord Adams
Joel Sendek – Lazard Capital
Jeremiah Shepard – Wedbush
» Cytokinetics, Inc. Q1 2009 Earnings Call Transcript
» Cytokinetics, Inc. Q4 2008 Earnings Call Transcript
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 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.
I will then provide some brief comments with respect to our financials and investment in research and development activity. And Robert will then conclude the call with additional comments regarding our recent activities and discuss the projected milestones for the remainder of 2010. We'll then open the call for a brief question-and-answer session.
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 and 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 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 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 only as of today. You should not rely on them as representing our views in the future and we undertake no obligation to update these statements after this call. I'll now turn the call over to Robert.
Thank you, Sharon. During the first quarter, Cytokinetics continued to build on the important momentum, we established in 2009, with the successful execution of key development milestones related to our skeletal muscle activator, CK-2017357 or CK-357. On the heels of positive Phase I data announced during the quarter, CK-357 entered the first of two Phase IIa, evidence of effect trials that we have planned for 2010.
This particular trial, in patients with Amyotrophic Lateral Sclerosis, or ALS, also commonly known as Lou Gehrig's disease, was open to enrollment in the first quarter and subsequently dosed its first patients this month. We believe that this hypothesis-generating clinical trial could provide key insights into the potential effects of this drug candidate's novel mechanism, which may increase the functional status of patients with ALS.
Furthermore, if increases in skeletal muscle function can be demonstrated in patients with ALS, they may translate similarly into other neuromuscular diseases and conditions associated with impaired neuromuscular function. Finally, the potential therapeutic value of this program was further highlighted during the quarter as the U.S. Food and Drug Administration granted CK-357 orphan drug status as a potential treatment for patients with ALS.
Andy will outline how this designation could hold certain advantages for Cytokinetics. Our heart failure program partnered with Amgen continues to make progress with multiple clinical trials planned through the remainder of the year. I am pleased to announce today that the two companies have been engaged in planning an expansion of our previously announced plans, to now also include a separate initiative, that is intended to advance an intravenous formulation of omecamtiv mecarbil into a Phase IIb clinical trial in 2010.
As I will discuss later in the call, this trial is expected to proceed concurrent with the previously announced plans for pharmacokinetic studies of two oral formulations of omecamtiv mecarbil in 2010. Amgen continues to be a highly-engaged partner that is planning effectively to progress this novel drug candidate and we are pleased to be working alongside them in the joint development of omecamtiv mecarbil for the potential treatment of heart failure.
As you will hear from both Andy and Sharon in a moment, in the last quarter, we believe we executed well on aggressive clinical development timelines and have done so in a fiscally responsible manner for the benefit of all of our stakeholders. I will 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 as well as to provide some insights into our plans for the future.
Thank you, Robert. In the first quarter, we achieved several high priority clinical development objectives for the lead drug candidate from our skeletal muscle activator program, CK-357. As Robert noted, we completed two Phase I trials and opened our first Phase IIa trial of CK-357, all in the first quarter. To put into perspective, the extent of all that we have achieved in these last few months, consider that during the last quarter, we completed patient enrollment in the second of our two Phase I clinical trials.