(Source: MARKETWIRE)
Cytokinetics, Incorporated (NASDAQ: CYTK) reported revenues from research and development collaborations of $71.9 million for the second quarter of 2009. Of this revenue, $50.0 million was related to Amgen's payment for the exercise of its option to an exclusive worldwide license (excluding Japan) to the company's cardiac contractility program, including omecamtiv mecarbil (formerly CK-1827452), and $21.4 million was related to the recognition of the remaining deferred revenue associated with Amgen's December 2006 non-exclusive license and technology access fee under the parties' collaboration and option agreement. The net income for the second quarter was $56.0 million, or $0.99 and $0.98 per basic and diluted shares, respectively. This compared to a net loss of $15.4 million, or $0.31 per basic and diluted share, for the same period in 2008. As of June 30, 2009, cash, cash equivalents and investments, excluding restricted cash and the put option on the company's auction rate securities, totaled $132.0 million
"Cytokinetics executed effectively on key activities in the second quarter, which we believe positions the company well both financially and operationally, to advance our pipeline with emphasis to our drug candidates that leverage our muscle contractility expertise," stated Robert I. Blum, Cytokinetics' President and Chief Executive Officer. "We are pleased that Amgen recently exercised its option to our cardiac contractility program and look forward to our continuing collaboration. We now proceed with over two years of cash at our current burn rate and a portfolio of five novel compounds in development highlighted by our recent advancement of CK-2017357 into a first-time-in-humans Phase I clinical trial."
Company Highlights
Muscle Contractility
Omecamtiv Mecarbil (formerly CK-1827452)
-- In May, Cytokinetics announced that Amgen exercised its option to obtain an exclusive worldwide license (excluding Japan) to the company's cardiac contractility program. The license includes omecamtiv mecarbil (formerly CK-1827452), a novel cardiac muscle myosin activator being developed for the potential treatment of heart failure. -- During the second quarter, Cytokinetics received notification from the United States Adopted Names (USAN) Council indicating the adoption of omecamtiv mecarbil as the USAN or generic name for CK-1827452. This information has been posted on the USAN website (www.ama-assn.org/go/usan). Information on omecamtiv mecarbil is planned to be submitted to the United States Pharmacopeial Convention, Inc. for publication in the USP Dictionary of USAN and International Drug Names. -- In June, investigators presented final data from a Phase IIa clinical trial of omecamtiv mecarbil in patients with stable heart failure as part of the Late Breaking Trials Session of the 2009 Heart Failure Congress of the European Society of Cardiology in Nice, France. This presentation included the first public disclosure of analyses showing that patients with reduced stroke volumes ( < 50ml) 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 trial. The authors concluded that these findings support further study and translation of this novel mechanism into patients with heart failure. In addition, a poster presentation containing data from the same trial compared the standard, image-based method for calculating left ventricular ejection fraction with "hybrid" methods that use a combination of image-based measurements of ventricular volumes and Doppler-derived measurements of stroke volume. The authors concluded that hybrid ejection fraction calculations relating Doppler-derived stroke volume to an image-derived ventricular volume may be more sensitive to increases in systolic function than assessments of ejection fraction based entirely on imaging. -- Also at the 2009 Heart Failure Congress of the European Society of Cardiology, investigators presented a poster containing final data from a Phase IIa clinical trial evaluating 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 concentrations that increase cardiac function did not deleteriously affect a broad range of safety assessments in the setting of exercise. -- The Phase IIa clinical trial of omecamtiv mecarbil designed to evaluate and compare the oral pharmacokinetics of both a modified-release and an immediate-release formulation in patients with stable heart failure continues to enroll patients. Based on results from this open-label trial, Cytokinetics and Amgen have agreed to proceed with a modified-release oral formulation in the planned Phase IIb clinical trials. -- Cytokinetics and Amgen have agreed to discontinue the Phase IIa clinical trial evaluating an intravenous formulation of omecamtiv mecarbil in patients with stable heart failure undergoing clinically indicated coronary angiography in the cardiac catheterization laboratory. This decision, made jointly by the companies, was due to the challenges of the current trial design and the constraints on enrolling eligible and consenting patients. The companies may revisit the objectives of this trial in the context of the ongoing development program.
CK-2017357
-- In June, Cytokinetics initiated a first-time-in-humans, Phase I clinical trial of CK-2017357 in healthy male volunteers. CK-2017357 is a fast skeletal muscle troponin activator and is the lead drug candidate that has emerged from the company's skeletal sarcomere activator program. Cytokinetics continues to enroll and dose-escalate subjects in this trial.
Smooth Muscle Program
-- In May, at the American Society of Hypertension 24th Annual Scientific Meeting and Exposition, Cytokinetics presented non-clinical data suggesting that direct inhibition of smooth muscle myosin may offer a novel therapeutic approach for the treatment of hypertension.
Oncology
-- In June, at the Annual Meeting of the American Society of Clinical Oncology (ASCO), Cytokinetics presented interim data from the Phase I portion of a Phase I/II clinical trial evaluating ispinesib administered as monotherapy as a first-line treatment in chemotherapy-naive patients with locally advanced or metastatic breast cancer. Cytokinetics continues the Phase I portion of this trial. -- At ASCO, Cytokinetics presented interim data from the Phase I portion of a Phase I/II clinical trial evaluating SB-743921 in patients with Hodgkin or non-Hodgkin lymphoma. Cytokinetics continues the Phase I portion of this trial. -- Also at ASCO, GlaxoSmithKline (GSK) presented interim data from the Phase I, first-time-in-humans clinical trial evaluating GSK-923295 in patients with advanced, refractory solid tumors. GSK continues to enroll and dose-escalate patients in this trial.
Corporate
-- In May, Cytokinetics announced a registered direct offering to certain of its existing institutional shareholders to sell an aggregate of 7,106,600 units. Each unit consisted of one share of Cytokinetics' common stock and one warrant to purchase 0.5 shares of Cytokinetics' common stock. Gross proceeds were approximately $14.0 million before deducting placement agents' fees and estimated offering expenses.
Financials
Revenues from research and development (R&D) collaborations for the second quarter of 2009 were $71.9 million, compared to $3.1 million for the same period in 2008. Revenues for the second quarter of 2009 and 2008 were primarily derived from the company's collaboration and option agreement with Amgen. The revenue in the second quarter of 2009 included Amgen's payment of $50.0 million related to the exercise of its option to an exclusive worldwide license (excluding Japan) to the company's cardiac contractility program, including omecamtiv mecarbil, and the recognition of the remaining deferred revenue of $21.4 million associated with Amgen's December 2006 non-exclusive license and technology access fee to omecamtiv mecarbil.
Total R&D expenses in the second quarter of 2009 were $10.2 million, compared to $14.9 million for the same period in 2008. The decrease in R&D expenses in the second 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 and laboratory expenses.
Total General and administrative (G&A) expenses for the second quarter of 2009 were $4.1 million, compared to $4.3 million for the same period in 2008. The decrease in G&A expenses in the second quarter of 2009, compared to the same period in 2008, was primarily due to lower spending for legal and outside services, which were offset in part by higher personnel-related costs.
Total Interest and other, net expense for the second quarter of 2009 was $1.6 million, compared to income of $0.7 million for 2008. The increase in Interest and other, net in 2009, compared to the same period in 2008 was primarily due to the recognition of $1.6 million in the non-cash fair value expense for the warrants associated with our May 2009 registered direct financing, along with a decline of $0.7 million in interest income as a result of lower market interest rates earned on our investments and lower average balances of cash, cash equivalents and investments.
