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cytokinetics inc (CYTK) Key Developments

Cytokinetics, Incorporated Presents at 26th Annual Piper Jaffray Healthcare Conference, Dec-03-2014 02:00 PM

Cytokinetics, Incorporated Presents at 26th Annual Piper Jaffray Healthcare Conference, Dec-03-2014 02:00 PM. Venue: The New York Palace Hotel, 455 Madison Ave, New York, NY 10022, United States. Speakers: Robert I. Blum, Chief Executive Officer, President, Director and Chief Executive of the Biopharmaceutical Concern.

Cytokinetics, Incorporated Reports Earnings Results for the Third Quarter and Nine Months Ended September 30, 2014; Provides Earnings Guidance for the Year 2014

Cytokinetics, Incorporated reported earnings results for the third quarter and nine months ended September 30, 2014. For the quarter, the company’s net loss was $6.0 million, or $0.16 per basic and diluted share. This is compared to a net loss for the same period in 2013, of $12.6 million, or $0.43 per basic and diluted share. Revenues were $9.4 million, compared to $4.5 million during the same period in 2013. Revenues for the third quarter of 2014 included $4.8 million of research and development revenues and $2.7 million of license revenues from the company's collaboration with Astellas, and $1.9 million of research and development revenues From the company's collaboration with Amgen. Operating loss was $5.998 million against $12.611 million a year ago. For the nine months, the company’s revenues were $25.2 million, compared to $6.3 million for the same period in 2013. Revenues for the first nine months of 2014 were primarily comprised of $14.1 million of research and development revenues and $7.6 million of license revenues From the company's collaboration with Astellas, and $3.4 million of research and development revenues From the company's collaboration with Amgen. Net loss was $23.1 million, or $0.65 per basic and diluted share, compared to a net loss of $40.2 million, or $1.52 per basic and diluted share, for the same period in 2013. Operating loss was $23.175 million against $40.326 million a year ago. The company provided updated financial guidance for 2014: cash revenues are expected to be approximately $19 to $21 million, cash R&D expenses are expected to be in the range of $45 to $48 million, and cash G&A expenses are expected to be in the range of $15 to $17 million. This financial guidance is on a cash basis and does not include the deferral of approximately $11 million in revenue associated with the Astellas and Amgen collaborations and an estimated $3.6 million in non-cash related operating expenses primarily related to stock compensation expense.

Cytokinetics, Incorporated Provides Update on Omecamtiv Mecarbil

Cytokinetics, Incorporated provided an update relating to omecamtiv mecarbil, the company’s drug candidate from its cardiac muscle contractility program. The company announced that COSMIC-HF (Chronic Oral Study of Myosin Activation to Increase Contractility in Heart Failure) has enrolled over 275 patients towards the objective of 450 patients in the ongoing expansion phase of the trial. In addition, over 70 patients have completed the 20 weeks of dosing in the expansion phase of COSMIC-HF. Recently, the Data Monitoring Committee reviewed data from COSMIC-HF and recommended that the trial continue without any changes to the protocol. Patient enrollment in COSMIC-HF is expected to conclude by the end of 2014. The company also announced that CY 1211, a phase I study comparing the tolerability and pharmacokinetics of omecamtiv mecarbil between Japanese and Caucasian healthy volunteers, is complete and indicates no clinically meaningful differences between the two groups studied. Data from CY 1211 are expected to inform plans for the development of omecamtiv mecarbil in Japan and the inclusion of Japan in potential global Phase III program activities. COSMIC-HF is a double-blind, randomized, placebo-controlled, multicenter, dose escalation study designed to assess the pharmacokinetics and tolerability of three oral modified-release formulations of omecamtiv mecarbil in patients with heart failure and left ventricular systolic dysfunction, and to select one formulation for further evaluation. During the dose escalation phase, approximately 40 patients were randomized 1:1:1:1 to placebo or one of three different oral formulations of omecamtiv mecarbil in each of two ascending dose escalation cohorts to enable selection of one of these oral formulations for the expansion phase of the trial. Omecamtiv mecarbil is a novel cardiac myosin activator and is the subject of collaboration between Cytokinetics and Amgen. Cardiac myosin is the cytoskeletal motor protein in the cardiac muscle cell that is directly responsible for converting chemical energy into the mechanical force resulting in cardiac contraction.

Cytokinetics, Incorporated Provides Development Program Update for Tirasemtiv

Cytokinetics, Incorporated provided a program update relating to tirasemtiv, the company's lead drug candidate from its skeletal muscle contractility program. The company announced that it has completed its review of results from BENEFIT-ALS (Blinded Evaluation of Neuromuscular Effects and Functional Improvement with Tirasemtiv in ALS) and has concluded that effects observed on Slow Vital Capacity (SVC) in patients treated with tirasemtiv are robust and potentially clinically meaningful. In addition, following consultation with clinical and statistical experts, the company believes that data from BENEFIT-ALS support progression of tirasemtiv to a potential Phase III clinical trial in patients with amyotrophic lateral sclerosis (ALS). The company also announced that it has begun regulatory interactions with the U.S. Food and Drug Administration (FDA) regarding results from BENEFIT-ALS and has received initial feedback from the FDA. The company believes that effects on SVC could be a Phase III clinical trial endpoint and could support registration of tirasemtiv as a potential treatment for patients with ALS. As a result, Cytokinetics has initiated planning for a potential Phase III clinical trial of tirasemtiv that could begin in 2015.

Cytokinetics, Incorporated to Report Q3, 2014 Results on Oct 30, 2014

Cytokinetics, Incorporated announced that they will report Q3, 2014 results at 4:30 PM, US Eastern Standard Time on Oct 30, 2014

 

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