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Cytokinetics, Inc. (CYTK)
Investor Event on ATOMIC-AHF Data at the ESC Conference Call
September 03, 2013 08:00 am ET
Robert I. Blum – President and Chief Executive Officer
John R. Teerlink – Professor of Medicine-University of California San Francisco
John J. V. McMurray – Professor of Medical Cardiology-University of Glasgow
Fady I. Malik – Senior Vice President-Research and Early Development
Andrew A. Wolff – Senior Vice President-Clinical Research and Development and Chief Medical Officer
Ritu Baral – Canaccord Genuity, Inc.
Robert I. Blum
Previous Statements by CYTK
» Cytokinetics Investor Event ATOMIC-AHF Data at the ESC (Webcast)
» Cytokinetics' CEO Discusses Q2 2013 Results - Earnings Call Transcript
» Cytokinetics Inc. (CYTK) Management Discusses Q2 2013 Results (Webcast)
I am very pleased to be joined today by members of Cytokinetics senior management team, as well as special guests. Here on slide number 4, you see that I am joined by Fady Malik, Physician, Scientist, Senior Vice President Research and Early Development and a Cardiologist.
Fady is a member of the management team who joined Cytokinetics back in 1998. Fady was Cytokinetics first employee and it’s his vision with regard to the original mechanistic and therapeutic hypothesis that we’ve been executing on in connection with our muscle biology related research and development. He has been responsible for the research and translational medicine and this is very proud day for all of us and then especially for Fady in light of today’s announcements regarding omecamtiv mecarbil.
I am also joined by Andy Wolff, also a Cardiologist, a member of our senior management team since 2004. Andy is our Head of Clinical Research and Development and Chief Medical Officer. Andy took a quite significant role in the design of our clinical studies including this trial ATOMIC-AHF that we’ll be speaking about today. By now I speak also for Andy in connection with this being a proud moment for him and the company.
Today we are also joined by two special guest, Dr. John McMurray and Dr. John Teerlink. John and John are both cardiologist who have been involved in the development and clinical research of omecamtiv mecarbil for some time. I think they bring quite excellent credentials and credibility to the study and evaluation of omecamtiv mecarbil and they have been involved with the studies since the early clinical trials and through to also this study, ATOMIC-AHF, that we’ll be speaking about and I am very pleased that they’ve been able to join us today to provide both the results from the study and also commentary and perspective.
Here on slide number five is our agenda for today, I’ll be making some opening remarks. Then John Teerlink will provide results of ATOMIC-AHF. John just presented these data here in Amsterdam at the European Society, amongst his professional colleagues and now we are very grateful for him also joining us for this investor event.
John McMurray will then follow John Teerlink and provide commentary in perspective about the unmet need in heart failure and also where these results may fit into that place for drug development and opportunities to address the clinical unmet need.
Fady Malik will then take the podium and talk about the program and its overview, some of the original therapeutic hypothesis we had for a small molecule cardiac myosin activator, where the ATOMIC results fit into that and how we now are proceeding development with ATOMIC results towards other results that we expect from other ongoing studies.
Andy Wolff will then lead a question-and-answer session both for those of you here in Amsterdam, as well as those participating in the webcast. I encourage you to e-mail your questions, so that we can ensure they get a proper response. I will then make some concluding remarks.
I’d now like to make a few comments about omecamtiv mecarbil, our heart failure program and also the heart failure syndrome around which omecamtiv mecarbil has been designed and is been developed.
Heart failure is a complex clinical syndrome. It’s a physiologic state in which cardiac output is insufficient to meet the needs of the body and lungs. It’s a chronic condition with an urgent unmet need. It’s a fast growing population tied to ageing demographics and about one-half to two-thirds of patients with heart failure have compromised left ventricular function or systolic dysfunction. Those are the patients to whom we are addressing the development of omecamtiv mecarbil with the hope that this drug candidate may result in improved cardiac performance, improved cardiac muscle contractility and potentially increased cardiac output.
Heart failure is typically classified as is described on this slide. By the New York Heart Association categorization, the U.S. population of heart failure is estimated to be approximately 5 million patients with the majority of them being Class II or Class III heart failure patients. There is a high unmet need given current standards of care in this disease area. There are opportunities both in the acute and chronic setting for novel mechanism evidenced based therapies to reduce mortality and hospital readmission, there are the absence of treatments to increase cardiac performance without associated liabilities currently as it is seem with Inotropic Therapy which will increase cardiac output, but also associated a potential increased mortality risk linked to increases in heart rate and arrhythmias.
Heart failure therapies in terms of the acute care and chronic care are depicted on this slide. You can see that there is an armamentarium of existing drugs that fall into different categories to treat this complex syndrome and inotropes those drugs useful for the expected objective of increasing cardiac performance represent depending on how you look at it about 10% to 20% of the acute heart failure therapies despite their limitation and the goal with the omecamtiv mecarbil program is to develop a medicine that may improve cardiac contractility without associated liabilities and increased mortality risk.