Investor Relations (IR) Questions: Cytokinetics Inc CYTK
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Answers received: March 2013
1) When is the last time CYTK raised cash through an offering (diluted)?
In June 2012, Cytokinetics announced two separate concurrent, underwritten offerings of shares of its common stock and accompanying warrants and shares of its Series B Convertible Preferred Stock ("Series B") and accompanying warrants. In aggregate for the concurrent offerings, the company issued 55.9 million shares of common stock, 23,026 shares of Series B Convertible Preferred Stock and warrants to purchase 47.4 million shares of its common stock at an exercise price of $0.88 per share. Cytokinetics received gross proceeds of $60.0 million from these offerings before deducting the issuance costs.
2) How much cash (not cash equivalents) does CYTK have?
The company only invests in Money-Market and U.S. Treasuries which consider to represent our total cash, which at 12/31/12 was $74.0 millin
3) What and approximately when is the next known catalyst?
Data is expected mid-year 2013 from the ATOMIC-AHF Phase IIb clinical trial. In November 2013, Cytokinetics announced the opening to enrollment of the third and final cohort of the ongoing, international, randomized, double-blind, placebo-controlled, Phase IIb clinical trial of an intravenous formulation of omecamtiv mecarbil, known as ATOMIC-AHF (Acute Treatment with omecamtiv mecarbil to Increase Contractility in Acute Heart Failure). This trial is sponsored by Amgen in collaboration with Cytokinetics and is designed to evaluate the safety, tolerability, and efficacy of omecamtiv mecarbil in patients with left ventricular systolic dysfunction who are hospitalized with acute heart failure. Additional information about ATOMIC-AHF can be found atwww.clinicaltrials.gov.
Also, data is expected by the end of 2013 from the BENEFIT-ALS, Phase IIb clinical trial. In October 2013, Cytokinetics announced the opening to enrollment of BENEFIT-ALS (Blinded Evaluation of Neuromuscular Effects and Functional Improvement with tirasemtiv in ALS), a Phase IIb, multi-national, double-blind, randomized, placebo-controlled clinical trial designed to evaluate the safety, tolerability and potential efficacy of tirasemtiv in patients with amyotrophic lateral sclerosis (ALS). This trial is designed to randomize approximately 400 patients to 12 weeks of double-blind treatment with tirasemtiv or placebo. The primary analysis of BENEFIT-ALS will compare the mean change from baseline in the ALS Functional Rating Scale in its revised form (ALSFRS-R) on tirasemtiv versus placebo. Secondary endpoints will include Maximum Voluntary Ventilation (MVV) and measures of skeletal muscle function. Cytokinetics plans to conduct BENEFIT-ALS at over 70 sites across the United States, Canada, and several European countries. Additional information about this trial can be found at www.clinicaltrials.gov.
Also, important to note is that Cytokinetics announced in February 2013, the opening to enrollment of a Phase II clinical trial of oral formulations of omecamtiv mecarbil. This trial, known as COSMIC-HF (Chronic Oral Study of Myosin Activation to Increase Contractility in Heart Failure), is sponsored by Amgen in collaboration with Cytokinetics and is designed to evaluate the safety and efficacy of a novel cardiac muscle myosin activator, omecamtiv mecarbil, in patients with heart failure and left ventricular systolic dysfunction. COSMIC-HF is a double-blind, randomized, placebo-controlled, multicenter, dose escalation study designed to select and evaluate an oral modified-release formulation of omecamtiv mecarbil in patients with heart failure and left ventricular systolic dysfunction. During the dose escalation phase, approximately 40 patients will be randomized 1:1:1:1 to placebo or one of three different oral formulations of omecamtiv mecarbil in each of two ascending dose pharmacokinetic (PK) cohorts to enable selection of one of these oral formulations for the planned expansion phase of the trial. The dose of omecamtiv mecarbil will be 25 mg twice daily in the first PK cohort and 50 mg twice daily in the second PK cohort. Following the dose escalation phase of the trial, there is a planned expansion phase of the trial in which approximately 300 patients will be randomized 1:1:1 to receive one oral formulation of omecamtiv mecarbil selected from the three studied in the prior ascending dose PK cohorts at one of two dose levels or placebo. The two dose levels of omecamtiv mecarbil to be studied in the expansion cohort will be based on the data from the ascending dose PK cohorts. The primary objectives of this study are to select an oral modified-release formulation and dose of omecamtiv mecarbil for chronic twice daily dosing in patients with heart failure and left ventricular systolic dysfunction and to characterize its safety, tolerability, and pharmacokinetics after 12 weeks of treatment. The secondary objectives are to assess the changes from baseline in systolic ejection time, stroke volume, left ventricular end-systolic diameter, left ventricular end-diastolic diameter, heart rate and N-terminal pro-brain natriuretic peptide (a biomarker associated with the severity of heart failure) after 12 weeks of treatment.
4) What is CYTK's quarterly cash burn?
The company only provides annual guidance with respect to cash burn. We estimate our cash burn to be between $51 to $54 Million in 2013
5) Does CYTK have an existing line of credit and if so how much can they draw against it? The company does not have a line of credit.
*************************
JODI GOLDSTEIN
Manager, Marketing & Corporate Communications
CYTOKINETICS, INC.
1) When is the last time CYTK raised cash through an offering (diluted)?
In June 2012, Cytokinetics announced two separate concurrent, underwritten offerings of shares of its common stock and accompanying warrants and shares of its Series B Convertible Preferred Stock ("Series B") and accompanying warrants. In aggregate for the concurrent offerings, the company issued 55.9 million shares of common stock, 23,026 shares of Series B Convertible Preferred Stock and warrants to purchase 47.4 million shares of its common stock at an exercise price of $0.88 per share. Cytokinetics received gross proceeds of $60.0 million from these offerings before deducting the issuance costs.
2) How much cash (not cash equivalents) does CYTK have?
The company only invests in Money-Market and U.S. Treasuries which consider to represent our total cash, which at 12/31/12 was $74.0 millin
3) What and approximately when is the next known catalyst?
Data is expected mid-year 2013 from the ATOMIC-AHF Phase IIb clinical trial. In November 2013, Cytokinetics announced the opening to enrollment of the third and final cohort of the ongoing, international, randomized, double-blind, placebo-controlled, Phase IIb clinical trial of an intravenous formulation of omecamtiv mecarbil, known as ATOMIC-AHF (Acute Treatment with omecamtiv mecarbil to Increase Contractility in Acute Heart Failure). This trial is sponsored by Amgen in collaboration with Cytokinetics and is designed to evaluate the safety, tolerability, and efficacy of omecamtiv mecarbil in patients with left ventricular systolic dysfunction who are hospitalized with acute heart failure. Additional information about ATOMIC-AHF can be found atwww.clinicaltrials.gov.
Also, data is expected by the end of 2013 from the BENEFIT-ALS, Phase IIb clinical trial. In October 2013, Cytokinetics announced the opening to enrollment of BENEFIT-ALS (Blinded Evaluation of Neuromuscular Effects and Functional Improvement with tirasemtiv in ALS), a Phase IIb, multi-national, double-blind, randomized, placebo-controlled clinical trial designed to evaluate the safety, tolerability and potential efficacy of tirasemtiv in patients with amyotrophic lateral sclerosis (ALS). This trial is designed to randomize approximately 400 patients to 12 weeks of double-blind treatment with tirasemtiv or placebo. The primary analysis of BENEFIT-ALS will compare the mean change from baseline in the ALS Functional Rating Scale in its revised form (ALSFRS-R) on tirasemtiv versus placebo. Secondary endpoints will include Maximum Voluntary Ventilation (MVV) and measures of skeletal muscle function. Cytokinetics plans to conduct BENEFIT-ALS at over 70 sites across the United States, Canada, and several European countries. Additional information about this trial can be found at www.clinicaltrials.gov.
Also, important to note is that Cytokinetics announced in February 2013, the opening to enrollment of a Phase II clinical trial of oral formulations of omecamtiv mecarbil. This trial, known as COSMIC-HF (Chronic Oral Study of Myosin Activation to Increase Contractility in Heart Failure), is sponsored by Amgen in collaboration with Cytokinetics and is designed to evaluate the safety and efficacy of a novel cardiac muscle myosin activator, omecamtiv mecarbil, in patients with heart failure and left ventricular systolic dysfunction. COSMIC-HF is a double-blind, randomized, placebo-controlled, multicenter, dose escalation study designed to select and evaluate an oral modified-release formulation of omecamtiv mecarbil in patients with heart failure and left ventricular systolic dysfunction. During the dose escalation phase, approximately 40 patients will be randomized 1:1:1:1 to placebo or one of three different oral formulations of omecamtiv mecarbil in each of two ascending dose pharmacokinetic (PK) cohorts to enable selection of one of these oral formulations for the planned expansion phase of the trial. The dose of omecamtiv mecarbil will be 25 mg twice daily in the first PK cohort and 50 mg twice daily in the second PK cohort. Following the dose escalation phase of the trial, there is a planned expansion phase of the trial in which approximately 300 patients will be randomized 1:1:1 to receive one oral formulation of omecamtiv mecarbil selected from the three studied in the prior ascending dose PK cohorts at one of two dose levels or placebo. The two dose levels of omecamtiv mecarbil to be studied in the expansion cohort will be based on the data from the ascending dose PK cohorts. The primary objectives of this study are to select an oral modified-release formulation and dose of omecamtiv mecarbil for chronic twice daily dosing in patients with heart failure and left ventricular systolic dysfunction and to characterize its safety, tolerability, and pharmacokinetics after 12 weeks of treatment. The secondary objectives are to assess the changes from baseline in systolic ejection time, stroke volume, left ventricular end-systolic diameter, left ventricular end-diastolic diameter, heart rate and N-terminal pro-brain natriuretic peptide (a biomarker associated with the severity of heart failure) after 12 weeks of treatment.
4) What is CYTK's quarterly cash burn?
The company only provides annual guidance with respect to cash burn. We estimate our cash burn to be between $51 to $54 Million in 2013
5) Does CYTK have an existing line of credit and if so how much can they draw against it? The company does not have a line of credit.
*************************
JODI GOLDSTEIN
Manager, Marketing & Corporate Communications
CYTOKINETICS, INC.