Cytokinetics, Incorporated (CYTK)
Q4 2012 Results Earnings Call
February 5, 2013 4:30 PM ET
Sharon Barbari - Executive Vice President, Finance and CFO
Robert Blum - President and CEO
Dr. Andrew Wolff - SVP, Clinical Research and Development and CMO
Dr. Fady Malik - SVP, Research and Early Development
Simos Simeonidis - Cowen and Company
Charles Duncan - Piper Jaffray
Ritu Baral - Canaccord
Mike King - JMP Securities
Jason Butler - JMP Securities
George Zavoico - MLV
Chad Messer - Needham
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I will now turn the call over to Sharon Barbari, Cytokinetics Executive 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; Dr. Andrew Wolff, Senior Vice President of Clinical Research and Development and Chief Medical Officer; and Dr. Fady Malik, Senior Vice President of Research and Early Development.
Following the forward-looking statement disclaimer, Robert will provide an overview of the past quarter, highlighting advancements in our clinical development program. Andy will then detail recent progress in our clinical development of tirasemtiv for the potential treatment of ALS, and Fady will update you regarding recent progress in our clinical development of omecamtiv mecarbil for the potential treatment of heart failure.
I will then provide a financial overview and comments with respect to our cash position, details on our investments in research and development activities and our 2013 financial guidance. Robert will then conclude the call with additional comments regarding recent activities and expected next step and projected milestones for 2013 for our development programs. We’ll then open the call for questions-and-answers.
The following discussion, including our responses to questions, contain statements that constitute forward-looking statements for purposes of the Safe Harbor provisions of the Private Securities Litigation Act of 1995, including but not limited to statements relating to our financial guidance, to the initiation, enrollment, design, conduct, and results of clinical trials, and to other research and development activity. 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 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. We undertake no obligation to update these statements after this call.
Now, I’ll turn the call over to Robert.
Thank you, Sharon. 2012 was an important year for Cytokinetics and the progress we made in both of our clinical development programs during the fourth quarter is very exciting.
We focus on activities to key deliverables in 2012 from our cardiac and skeletal muscle programs that would lay the foundation for what we believe may prove to be a pivotal year for Cytokinetics in 2013.
The initiation of our Phase IIb clinical trial evaluating tirasemtiv in ALS now known as BENEFIT-ALS was one of those key deliverables. BENEFIT-ALS, which stands for Blinded Evaluation of Neuromuscular Effects and Functional Improvement with tirasemtiv in ALS is enrolling patients in North America and we expect very soon will be open to enrollment in Europe as well.
In January, we hosted the European investigators meeting for BENEFIT-ALS, and Andy will elaborate on that meeting and will also provide other details regarding BENEFIT-ALS in a moment. Until then, I will just say that the enthusiasm of the clinical investigators and other study personnel at both North American and European meetings is encouraging.
We are optimistic about our enrollment timelines for BENEFIT-ALS, which is expected to enroll 400 patients with ALS from over 70 sites throughout the U.S., Canada and Europe.
In November, we announced positive data from our Phase IIa, Evidence of Effect clinical trial known as CY 4023. That trial evaluated tirasemtiv in patients with generalized myasthenia gravis.
Andy will elaborate more on this trial in a moment. In brief, however, we are encouraged by these data because they demonstrate pharmacodynamic activity of the novel mechanism of tirasemtiv in another distinct population of patients in their muscular disease.
In addition to our recent progress with tirasemtiv in the last quarter, the clinical trials program for omecamtiv mecarbil also advanced to a key milestone. In November, we announced the opening of the third and final cohort of the ongoing Phase IIb clinical trial known as ATOMIC-AHF, which stands for acute treatment of omecamtiv mecarbil to increase contractility in Acute Heart Failure.
Enrollment momentum underscores the continued interest in omecamtiv mecarbil in the approximately 140 international centers participating in this trial. Alongside that progress, Cytokinetics and Amgen have been busily collaborating in preparations to launch another Phase IIb clinical trial, designed to evaluate modified-release oral formulations of omecamtiv mecarbil.
This next trial is named COSMIC-HF which stands for chronic oral study of myosin activation to increase contractility in heart failure and enrolling patients in heart failure and left ventricular systolic dysfunction is the goal. This Phase IIb trial is expected to inform the selection of one of these oral formulations for advancement into the Phase III clinical program.