Cytokinetics, Incorporated (CYTK)
Q1 2013 Earnings Call
April 30, 2013, 04:30 pm ET
Sharon Barbari - EVP, Finance & CFO
Robert Blum - President & CEO
Andrew Wolff - SVP, Clinical Research & Development, & Chief Medical Officer
Fady Malik - SVP, Research & Early Development
Simos Simeonidis - Cowen & Company
Charles Duncan - Piper Jaffray
Jason Butler - JMP Securities
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I will now turn the call over to Sharon Barbari, Cytokinetics’ Executive Vice President of Finance and Chief Financial Officer. 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 programs. Fady will then update you regarding recent progress in our clinical development of omecamtiv mecarbil for the potential treatment of heart failure, and Andy will then detail recent progress in our clinical development of tirasemtiv for the potential treatment of ALS and other neuromuscular diseases and he will also provide an update relating to CK-2127107 or CK-107, our follow-on fast skeletal muscle activator.
I will then provide a financial overview and comments with respect to our cash position and details on our investments in research and development activity. Robert will then conclude the call with additional comments regarding recent activities and expected next-steps and projected milestones for 2013 for our development stage programs. We’ll then open the call for questions.
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, incorporate partnering to the initiation, enrollment, design, conduct, and results of clinical trials, 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 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 report 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 presenting our views in the future. We undertake no obligation to update these statements after this call.
I'll now turn the call over to Robert.
Thank you, Sharon. 2013 is proceeding as planned to be a very important year for Cytokinetics. We anticipate that data from our two Phase IIb clinical trials will in form the progression of our most advanced programs into potential Phase III trials. The first quarter demonstrated our progression towards these key milestones and our movement forward towards potentially meaningful value inflection points for the company. Let me take a brief moment to highlight each of these milestones in a bit more detail.
During the last quarter, we reported that completion of enrollment in the third and final cohort in our Phase IIb clinical trial, ATOMIC-AHF which stands for acute treatment of omecamtiv mecarbil to increase contractility in Acute Heart Failure. It is particularly exciting for us to know that we will soon have clinical data that may allow us to assess the safety, tolerability, pharmacokinetics and pharmacodynamic effects of omecamtiv mecarbil in a high risk population of patients hospitalized with acutely decompensated heart failure.
Together with our partner Amgen, we are readying to lock the database to enable prospectively defined statistical analysis which we hope may demonstrate that omecamtiv mecarbil is both well tolerated and also shows clinically relevant effects in this rather sick population. Most importantly, we hope that ATOMIC-AHF will provide support of the evidence for advancing omecamtiv mecarbil into Phase III. Once the full results from ATOMIC-AHF are reviewed together with Amgen, we look forward to reporting the findings from this Phase IIb to be clinical trial; we continue to anticipate those results to be made public in mid-year 2013.
Underscoring further progress and an expansion of activities in our heart failure program, last month we announced the initiation of another Phase II clinical trial of omecamtiv mecarbil called COSMIC-HF which stands for Chronic Oral Study of Myosin Activation to Increase Contractility in Heart Failure. This trial is evaluating the pharmacokinetics of three oral formulations of omecamtiv mecarbil in patients with heart failure and left ventricular systolic dysfunction. We expect the results of this clinical trial to inform the selection of one of these oral formulations for possible advancement into the Phase III clinical program.
Fady will give you more color on the development of omecamtiv mecarbil in a few minutes, but I believe it is fair to summarize that 2013 offers much promise for the development of this novel drug candidate and we are working closely with Amgen to ensure that results can be available from ATOMIC-AHF and COSMIC-HF to inform next steps towards potentially going into Phase III.