Key Developments: Cytokinetics Inc (CYTK.PH)
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23 May 2013
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Latest Key Developments (Source: Significant Developments)
Cytokinetics, Inc. Raises FY 2012 Revenue Guidance
Cytokinetics, Inc. updated financial guidance for fiscal 2012 which incorporates the estimated costs associated with CY 4026. The Company anticipates revenue will be in the range of $5.0 to $7.0 million. Full Article
Cytokinetics, Inc. Announces $60 Million Financing
Cytokinetics, Inc. announced the pricing of concurrent, separate underwritten offerings of ; 55.9 million shares of its common stock and accompanying warrants to purchase 0.6 shares of common stock for each share purchased at a price to the public of $0.76 for each share of common stock and accompanying warrant, expected gross proceeds of $42.5 million, and 23,026 shares of its Series B Convertible Preferred Stock (Series B) and accompanying warrants to purchase 600 shares of common stock for each share of Series B purchased, at a price to the public of $760.00 for each share of Series B and accompanying warrants, for expected gross proceeds of $17.5 million. The Series B is non-voting and each share of Series B is convertible into 1000 shares of Cytokinetics common stock, provided that conversion will be prohibited if, as a result, the holder and its affiliates would own more than 9.98% of the total number of Cytokinetics shares of common stock then outstanding. The warrants in both offerings are exercisable at an exercise price of $0.88 per share beginning on the date of issuance and will expire on the fifth anniversary of the date of issuance. Cytokinetics expects to receive combined gross proceeds of approximately $60.0 million from these offerings, before deducting the estimated expenses. These offerings are expected to close on June 25, 2012. Full Article
Cytokinetics, Inc. Announces Proposed Public Offerings Of Common Stock And Warrants And Series B Convertible Preferred Stock
Cytokinetics, Inc. announced that it is concurrently offering to sell, subject to market and other conditions, (i) shares of its common stock and corresponding warrants to purchase 0.60 of a share of common stock for each share purchased, in an underwritten public offering, and (ii) shares of its Series B Convertible Preferred Stock (Series B) and corresponding warrants to purchase 600 shares of common stock for each share of Series B purchased, in a separate underwritten public offering. The Series B is non-voting and each share of Series B is convertible into 1000 shares of Cytokinetics common stock, provided that conversion will be prohibited if, as a result, the holder and its affiliates would own more than 9.98% of the total number of Cytokinetics shares of common stock then outstanding. All of the shares and warrants in these offerings are to be sold by Cytokinetics. Cowen and Company, LLC and JMP Securities LLC are acting as joint book-running managers of these offerings. Full Article
Cytokinetics, Inc. Announces Publication Of Phase II Evidence Of Effect Study Of CK-2017357 In Journal Amyotrophic
Cytokinetics, Inc. announced the publication of its Phase II Evidence of Effect (EoE) clinical study of CK-2017357, an orally bioavailable fast skeletal muscle troponin activator, in patients with amyotrophic lateral sclerosis (ALS). The results published online in the journal Amyotrophic Lateral Sclerosis demonstrated that single oral doses of 250 mg and 500 mg of CK-2017357 appeared safe and well-tolerated in patients with ALS that were studied. Measures of muscle endurance also appeared to be improved in a dose-related fashion in patients who received CK-2017357. In addition, patients who received CK-2017357, and their investigators, perceived a global benefit on treatment. Data from this study, which compared single doses of CK-2017357 to placebo, informed the design of subsequent studies conducted by Cytokinetics which have evaluated the safety and tolerability of CK-2017357 in other dosing regimens. Full Article
Cytokinetics, Inc. Reaffirms FY 2012 Revenue Guidance-Conference Call
Cytokinetics, Inc. announced that it expects fiscal 2012 revenue guidance provided between $4 million and $5 million is going to stand. Full Article
Cytokinetics, Inc. Announces Encouraging Results From Two Phase II Clinical Trials Evaluating CK-2017357 In Patients With Amyotrophic Lateral Sclerosis
Cytokinetics, Inc. announced encouraging results from two Phase II clinical trials evaluating CK-2017357 in patients with amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig's Disease. CK-2017357 was determined to be safe and well-tolerated when dosed with riluzole, the only approved treatment for ALS. The clinical trials results were reported in an oral presentation and a poster at the American Academy of Neurology 64th Annual Meeting in New Orleans, Louisiana. An oral presentation by Dr. Shefner titled A Study to Evaluate Safety and Tolerability of Repeated Doses of CK-2017357 (CK-357) in Patients with Amyotrophic Lateral Sclerosis included data from Part B of a two-part, randomized, double-blind, placebo-controlled, multiple dose, safety, tolerability, pharmacokinetic and pharmacodynamic clinical trial of CK-2017357 in patients with ALS (CY 4024). Dr. Shefner concluded that CK-2017357 appeared to be safe and well-tolerated dosed daily at 125 mg, 250 mg, and 375 for two weeks, and that encouraging trends were observed in the ALSFRS-R and MVV. As expected, plasma concentrations of CK-2017357 were unaffected by co-administration with riluzole, while riluzole levels increased during co-administration with CK-2017357. Adverse events and clinical assessments during treatment with CK-2017357 appeared similar, with or without co-administration of riluzole at the reduced dose of 50 mg daily. Full Article
Cytokinetics, Inc. Announces Initiation Of Phase I Clinical Trial Of Oral Formulations Of Omecamtiv Mecarbil In Healthy
Cytokinetics, Inc. announced the initiation of a Phase I study designed to assess the safety, tolerability and pharmacokinetics of multiple oral formulations of omecamtiv mecarbil in healthy volunteers. This clinical trial is being conducted by Amgen in collaboration with Cytokinetics and will be used to guide selection of an oral formulation of omecamtiv mecarbil for later-stage clinical trials. Amgen holds an exclusive worldwide (excluding Japan) license to omecamtiv mecarbil and related compounds, subject to specified development and commercialization participation of Cytokinetics. This Phase I clinical trial is a randomized, open-label, 4-way cross-over study designed. This Phase I clinical trial is a randomized, open-label, 4-way cross-over study designed to determine the oral bioavailability of multiple formulations of omecamtiv mecarbil in healthy subjects. Approximately 60 subjects will be enrolled in this study. Each subject will receive two of the six oral formulations included in the study, each administered as a single dose under fasted and fed conditions. The primary objective of this study is to determine the effect of food on the bioavailability of omecamtiv mecarbil when administered in multiple oral formulations. The secondary objectives are to evaluate the bioavailability, safety, tolerability and pharmacokinetic profiles of omecamtiv mecarbil when administered in multiple oral formulations. Full Article
Cytokinetics, Inc. Issues FY 2012 Revenue Guidance
Cytokinetics, Inc. announced that for fiscal 2012, it expects revenue to be in the range of $4 to $5 million. This financial guidance is on a cash basis and does not include an estimated $4.7 million in non-cash related operating expenses primarily related to stock compensation expense and the guidance includes expected restructuring charges and R&D and G&A expenses for 2012. Full Article
Cytokinetics, Inc. Sees Restructuring Charges In Q4 2011; Issues FY 2011 Revenue Guidance Below Analysts' Estimates
Cytokinetics, Inc. announced that for fiscal 2011, it expects incurring restructuring charges of approximately $1.3 million. Primarily associated with personnel-related termination costs which may be revised later in the year, depending on potential facility-related charges and other write-downs that have not yet been finalized. For fiscal 2011, it expects revenue to be in the range of $3.0 to $4.0 million, this guidance does not reflect potential revenue from potential collaborations with other partners as well as, the estimated one time restructuring costs of $1.3 million. According to I/B/E/S Estimates, analysts are expecting the Company to report revenues of $9 million for fiscal 2011. Full Article
Cytokinetics, Inc. Announces Strategic Restructuring
Cytokinetics, Inc. announced to restructure the Company's workforce and operations in connection with its commitment to focus resources primarily on the development of its later-stage development programs, CK-2017357 and omecamtiv mecarbil. As its first priority, the Company intends to focus its resources on the partnering and advancement of CK-2017357, including the planning and initiation of a clinical trial in amyotrophic lateral sclerosis (ALS) patients that may potentially serve as a registration trial. Additionally, Cytokinetics plans to retain a smaller, but fully integrated, R&D organization focused to the advancement of its follow-on skeletal muscle troponin activator program and certain other research and development programs also directed to muscle biology. Following the implementation of this restructuring program, Cytokinetics will have reduced its workforce to 83 people. The Company is providing severance, employee benefit continuation and career transition assistance to the employees directly affected by the restructuring. Cytokinetics anticipates incurring restructuring charges of approximately $1.3 million in the fourth quarter of 2011, primarily associated with personnel-related termination costs which may increase later in the year, depending on potential facility-related charges and other write downs that have not been finalized. Full Article
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