Cytokinetics Inc. (CYTK)
Q3 2012 Earnings Call
October 30, 2012 4:30 PM ET
Sharon Barbari – EVP-Finance and CFO
Robert Blum – President and CEO
Andy Wolff – SVP, Clinical Research and Development, and Chief Medical Officer
Fady Malik – SVP, Research and Early Development
Chad Messer – Needham & Company
Previous Statements by CYTK
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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, formerly known as CK-2017357, 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 and details on our investments in research and development activities. Robert will then conclude the call with additional comments regarding recent activities and expected next steps for our development programs. We will also update projected company milestones for the remainder of 2012. We will then open the call for questions and answers.
The following discussion, including our responses to questions, contain statements that constitute forward-looking statements for the purposes of the Safe Harbor provisions of the Private Securities Litigation Reform 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 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 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. During the third quarter, we made important advancements, capitalizing on the positive outcomes we achieved last quarter in both of our clinical-stage development programs. Since our last earnings call, we have made significant progress with our clinical development program for tirasemtiv, our drug candidate for the potential treatment of ALS. Relieving patients suffering caused by this devastating disease is of critical importance for us at Cytokinetics.
ALS just may be the most grievous illness I’ve encountered during my 30 years in this business. Anyone who knows someone with ALS understands that these patients ultimately can become prisoners in their own bodies. They suffer progressive neurological impairment over time, even as their cognitive abilities remain intact. They lose their muscle function and coordination, and ultimately may die of respiratory failure or closely related complications such as pneumonia.
Tirasemtiv may afford these patients an opportunity to improve or preserve key functional status that correlates with activities of daily living. We are fully committed to understanding whether the increases in skeletal muscle force and endurance that we have observed in smaller trials of shorter duration may now translate into clinically meaningful and durable effects in a larger and longer trial.
As evidence of our commitment to discovering and developing an effective treatment for ALS to benefit both patients and their caregivers, yesterday we announced that our Phase IIb clinical trial evaluating tirasemtiv in patients with ALS is now open to enrollment. Previously known as CY 4026, this trial now has a name, BENEFIT-ALS, which stands for Blinded Evaluation of Neuromuscular Affects and Functional Improvement with Tirasemtiv in ALS.
In September, we hosted an investigators’ meeting for BENEFIT-ALS. We had over 180 people there, and 53 of our 55 North American sites were represented. Andy will elaborate on this meeting and the BENEFIT-ALS trial in a moment. However, in the meantime, I will just say that the enthusiasm of the clinical investigators and other study personnel in attendance was extraordinary. We left this meeting feeling optimistic about how quickly we may enroll BENEFIT-ALS, which is expected to enroll 400 patients with ALS from over 70 sites throughout the U.S., Canada, and Europe.
In addition to our recent progress with tirasemtiv, the clinical trials program for omecamtiv mecarbil also significantly advanced to a key milestone. I am pleased to report that in the most recent quarter, patient enrollment was completed in the second cohort of the ongoing Phase IIb ATOMIC-AHF clinical trial. This second cohort enrolled substantially faster than the first cohort, underscoring increasing enthusiasm for omecamtiv mecarbil in the approximately 140 centers enrolling patients in this trial.