SOUTH SAN FRANCISCO, CA, Oct. 28, 2009 (Marketwire) --

SOUTH SAN FRANCISCO, CA -- (Marketwire) -- 10/28/09 -- Cytokinetics, Incorporated (NASDAQ: CYTK) reported revenues from research and development collaborations of $5.5 million for the third quarter of 2009. The net loss for the third quarter was $8.2 million, or $0.14 per basic and diluted share. This compared to a net loss of $16.3 million, or $0.33 per basic and diluted share, for the same period in 2008. As of September 30, 2009, cash, cash equivalents and investments, excluding restricted cash and the put option on the company's auction rate securities, totaled $119.2 million.

"The highlight of the most recent quarter was Cytokinetics' first Research and Development Day which gave our management team an opportunity to elaborate on our expanded portfolio of drug candidates directed to the biology of muscle function," stated Robert I. Blum, President and Chief Executive Officer of Cytokinetics. "In particular, we believe that the advancement of CK-2017357 towards Phase II trials positions us to benefit from knowledge arising from our cardiac muscle program that is progressing towards late-stage development. I believe we are realizing important technical synergies and capital allocation efficiencies as a function of our increased focus in our R&D activities."

Company Highlights

Muscle Contractility

• In September, Cytokinetics' hosted a Research and Development (R&D) Day at which the company detailed R&D strategies, data and plans relating to the company's expanded development pipeline focused on the biology of muscle function. Among the highlights was a review of the Phase IIa clinical trials data in heart failure patients from the ongoing clinical development program for omecamtiv mecarbil (formerly CK-1827452), a novel cardiac myosin activator, as well as non-clinical data supporting the advancement of CK-2017357, a fast skeletal muscle troponin activator and its potential applications in an array of neuromuscular diseases and medical conditions associated with muscle fatigue and wasting. In addition, the company highlighted its smooth muscle myosin inhibitor program and its potential application in diseases of vascular constriction and bronchoconstriction. The discussion which was led by Cytokinetics' senior management was supplemented by commentary by key opinion leaders who offered their perspectives on the clinical prospects for the drug candidates in Cytokinetics' development pipeline.

Omecamtiv Mecarbil

• In August, at the Annual Meeting of the European Society of Cardiology (ESC), and in September at the 2009 Heart Failure Society of America (HFSA) Annual Meeting, Cytokinetics presented final data from the Phase IIa clinical trial of omecamtiv mecarbil in stable heart failure patients. The authors concluded that patients with reduced stroke volumes ( < 50 mL) at baseline had generally greater pharmacodynamic responses to omecamtiv mecarbil than those in patients with greater stroke volumes at baseline, demonstrating robust pharmacodynamic activity in this more severely affected sub-population of patients from the study. Statistically significant increases in systolic ejection time, and in stroke volume, cardiac output, fractional shortening, and ejection fraction (all measures of cardiac function), occurred across the patient population in a concentration-dependent manner. In addition, the data demonstrated statistically significant correlations between increasing omecamtiv mecarbil plasma concentration and decreases in left ventricular end-systolic volume, left ventricular end-diastolic volume and heart rate.
• In August, at the Annual Meeting of the ESC, and in September at the 2009 HFSA Annual Meeting, Cytokinetics presented final data from the Phase IIa clinical trial of omecamtiv mecarbil in patients with ischemic cardiomyopathy and angina. The authors concluded that in these patients, who theoretically could be most vulnerable to the possible deleterious consequences of systolic ejection time prolongation, treatment with omecamtiv mecarbil, at plasma concentrations previously demonstrated in other Phase IIa trials to increase cardiac function, did not adversely affect a broad range of safety assessments in the setting of exercise.
• During the third quarter, the Phase IIa clinical trial designed to evaluate the pharmacokinetics of both modified and immediate release oral formulations of omecamtiv mecarbil in patients with stable heart failure continued to enroll patients.
• Cytokinetics and Amgen have agreed on next steps relating to the further development of omecamtiv mecarbil. The companies are planning a clinical trial designed to further assess the pharmacokinetics of both modified and immediate release oral formulations of omecamtiv mecarbil in patients with stable heart failure, using active pharmaceutical ingredient and drug product manufactured by Amgen. In addition, the companies are planning to conduct another pharmacokinetic trial to evaluate omecamtiv mecarbil in patients with renal dysfunction, along with additional pre-clinical activities. Cytokinetics and Amgen anticipate the initiation of the Phase IIb clinical trials program to occur in 2011, but the companies are discussing how the timeline could be accelerated into 2010.

CK-2071357

• CK-2017357 is the lead drug candidate from Cytokinetics' skeletal sarcomere activator program. Cytokinetics continues to dose healthy volunteers in a Phase I, first-time-in-humans, ascending, single-dose, double-blind, placebo-controlled clinical trial of CK-2017357 designed to assess the safety, tolerability, and pharmacokinetic profile of this drug candidate and to determine its maximum tolerated dose and plasma concentration. Although the trial is still ongoing and thus remains blinded, to date, no adverse events have been observed in trial participants to indicate that an intolerable dose has been administered. Consequently, the maximum tolerated dose has not yet been determined; however, doses that produced CK-2017357 blood levels associated with increased skeletal muscle function in preclinical models have been tolerated by the healthy volunteers in this study.

Financials

Revenues from research and development (R&D) collaborations for the third quarter of 2009 were $5.5 million, compared to $3.1 million for the same period in 2008. Revenues for the third quarter of 2009 and 2008 were primarily derived from the company's collaboration and option agreement with Amgen. Research and development revenues from Amgen for the third quarter of 2009 consisted of reimbursements of $5.5 million in program expenses under the parties' collaboration and option agreement. License revenues of $3.1 million for the third quarter of 2008 were associated with the December 2006 non-exclusive license and technology fee to omecamtiv mecarbil.

Total R&D expenses in the third quarter of 2009 were $9.9 million, compared to $13.5 million for the same period in 2008. The decrease in R&D expenses in the third quarter of 2009, compared to the same period in 2008, was primarily due to decreased spending related to the company's clinical and pre-clinical programs, and lower personnel expenses.

Total general and administrative (G&A) expenses for the third quarter of 2009 were $3.9 million, compared to $3.8 million for the same period in 2008. The increase in G&A expenses in the third quarter of 2009, compared to the same period in 2008, was primarily due to higher spending for outside services, offset in part by lower spending for legal services.

Total Interest and other, net income for the third quarter of 2009 was $6,000, compared to income of $0.5 million for 2008. The decrease in Interest and other, net in 2009, compared to the same period in 2008 was primarily due lower market interest rates earned on our investments.

The net loss for the three months ended September 30, 2009, was $8.2 million, or $0.14 per basic and diluted share, compared to a net loss for the same period in 2008 of $16.3 million, or $0.33 per share.

Cytokinetics also reported results of its operations for the nine months ended September 30, 2009. Revenues from R&D collaborations for the nine months ended September 30, 2009 were $80.5 million, compared to revenues of $9.3 million for the same period in 2008. Revenues for the first nine months of 2009 and 2008 were primarily derived from the company's collaboration and option agreement with Amgen.