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Cytokinetics' CEO Discusses Q2 2012 Results - Earnings Call Transcript

In April, we presented data from two different recently Phase II clinical trials in ALS patients. Having now completed four Phase I and four Phase II clinical trials of tirasemtiv that have in total and rolled over 100 volunteers and over 200 patients. We have learned a great deal about the safety, tolerability, pharmacokinetics and pharmacodynamics of tirasemtiv and have selected a dosing regimen for later stage studies of this novel mechanism drug candidate.

In addition, through our recent interactions with major regulatory authorities, including the U.S. Food and Drug Administration or FDA, and the European Medicines Agency or EMA, we believe we have identified end points that in upcoming potential registration trials may demonstrate sufficient clinical benefit of tirasemtiv in patients with ALS to support its' potential approval for the treatment of ALS.

As such, we believe we are now ready to advance tirasemtiv into a clinical trial's program designed to support its registration for the potential treatment of ALS beginning with a Phase IIb clinical trial we will call CY 4026. Accordingly, we submitted a protocol for CY 4026 to the FDA in the past quarter.

Also, during the quarter, we met with EMA's scientific advice working party to seek their advice regarding expanding the clinical development program for tirasemtiv to include countries in Europe. Andy will elaborate more on CY 4026 and our recent communications with these regulatory authorities in a moment.

As I mentioned last quarter, in order to insure that tirasemtiv is developed as efficiently and effectively as possible, and to maintain urgency in momentum for the potential benefit of ALS patients and their families, we have explored alternative ways to fund our program.

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