Cytokinetics, Incorporated (CYTK)

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Cytokinetics, Incorporated (CYTK)

Morgan Stanley Global Healthcare Conference

September 11, 2013, 10:35 AM ET


Sharon Barbari - Executive Vice President, Finance and Chief Financial Officer

Robert Blum - President and Chief Executive Officer


David Friedman - Morgan Stanley


David Friedman - Morgan Stanley

Thanks, everyone, for joining us. Dave Friedman, a biotech analyst. And I am joined by the team from Cytokinetics here. On the fireside is Sharon Barbari, Chief Financial Officer; on the nearside, Robert Blum, President and CEO. We'd love for this to be interactive. So please feel free at any point to raise your hand, and we'll make sure we get a microphone to you. And I thank you both for joining.

And maybe if we can just start for people who are not familiar with the company, if you can just give a couple minute overview. And then we'll go right into Q&A.

Robert Blum

So Cytokinetics is a company dedicated to small molecule therapeutics directed to proteins involved in mechanics of muscle biology. We have three principal programs that are of a development stage. One, partnered with Amgen, a small molecule activator of cardiac myosin, being developed for the potential treatment of heart failure. That's currently in Phase IIb stage development, hopefully moving into Phase III. So that's our cardiovascular muscle program.

Our skeletal muscle program is divided into two camps: one, a compound called tirasemtiv. It's an activator of fast switch skeletal component, being developed for the potential treatment of ALS that's also in Phase IIb. And then we have a second fast switch skeletal component activator in Phase I, that's partnered with Astellas for non-neuromuscular diseases. These three programs have all emerged out of our own research.

Cytokinetics is a pioneer and an expert and the leader in the area of muscle biology. The company is based in South San Francisco, roughly about 85 people, founded in 1998, and now emerging through to this late-stage clinical trials stage of development.

Question-and-Answer Session

David Friedman - Morgan Stanley

Great, thanks. So maybe if we can just start, most companies, and I'm not really sure how many at all that focus on sort of muscle biology and have an approach as unique as yours. So may be is there a way that you can just sort of briefly describe your general approach to creating drugs that have the impacts on how muscles actually function?

Robert Blum

So as far as we know we are the only company that has focused so exclusively to muscle and has built a pipeline and franchise around that. We think that it's especially important and well-timed in light of the unmet need in a number of key disease areas and also the aging demographics, where those are going to be congruence around muscle, as companies are focusing to metabolic diseases and other approaches to healthy aging, which will also lead on muscle.

We have an explicit understanding of the biochemistry and biophysics of how muscle proteins work in concert to achieve force and power. And for 15 years at Cytokinetics, and for decades, have preceded the formation at Cytokinetics. Scientists associated with the company have been working to mindless biology to understand its application to the potential for new pharmaceutical. So we harness that with what we're doing.

We have been the first ones to reconstitute the proteins involved in the sarcomere, which is the fundamental unit of muscle contractility and make industrial screening of drug candidates for activating muscle systems. And each of our program is directed to a different protein that is uniquely specific to the function of muscle in different tissue types and associated with different diseases.

David Friedman - Morgan Stanley

So does anyone have any questions, just on the basic sort of platform before we jump into the drugs specifically? So may be we can just start with omecamtiv, which is I think sort of most advanced drug, the one that had the most news lately and the most attention. So may be I guess if we can start with just the drug and what it was designed to do. And then we'll move on to the partnership and some of the data.

Robert Blum

Omecamtiv mecarbil was designed to be a more pure form of inotrope, if you want to use that word. A drug that improves cardiac performance, increases cardiac output, but unlike existing inotropes, drugs like dobutamine and milrinone and others that have been around for decades, do so in a way that doesn't also introduce risk of increased arrhythmias and other demands on the heart muscle.

So these other drugs that are available commercially and have them for some time, tend to be used sparingly. And we know a lot about their mechanism, they increase the amount of calcium that comes into the cardiac cell and increase cardiac muscle contractility, but do so in a way that's also associated with increased heart rate arrhythmias and death. A study called [indiscernible] demonstrated that these drugs improve cardiac output and cardiac performance, but also increase risk of mortality.

So we designed omecamtiv mecarbil very much at the molecular basis level to increase cardiac muscle contractility, but by a new mechanism. A mechanism that sensitizes the system to existing levels of calcium, as you'd find when the heart is contracting, a phase called systole, but not also at those levels of calcium found with diastole, when the heart is relaxing.

So in reconstituting the sarcomere, we found highly specific compounds specific for cardiac myosin. The mechanism of action of omecamtiv is novel, it's unique, it's increasing not the velocity of contraction as occurs with existing inotropes, but rather the duration. So the signature effect of omecamtiv mecarbil is by binding to myosin, it increases the tightly bound chemical state time, when myosin is bound to actin, it as if there are more hands pulling on the rope at the same time or more ores in the water creating more forced production that translates pharmacodynamically into an increase in duration of contractility and increase in systolic ejection time, which corresponds to increase ejection fraction, increased stroke volume.

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