Point72 Asset Management and Cytokinetics
Steven Cohen’s Point72 Asset Management, which was earlier known as SAC Capital, initiated a new position in Cytokinetics Inc. (CYTK) this month, according to a 13G filing. The filing revealed the fund owned 2,000,500 shares, representing a 5.5% stake in the company.
Cytokinetics is a clinical-stage biopharmaceutical company focused on the discovery and development of novel small molecule therapeutics that modulate muscle function for the potential treatment of serious diseases and medical conditions. Cytokinetics’ lead drug candidate from its skeletal muscle contractility program, Tirasemtiv (formerly known as CK-2017357), is a fast skeletal muscle troponin activator. Cytokinetics holds the rights to tirasemtiv and is independently developing this drug candidate for the potential treatment of amyotrophic lateral sclerosis or ALS and other neuromuscular disorders. It is currently conducting a Phase II clinical trials program for tirasemtiv, including an ongoing Phase IIb clinical trial in patients with ALS, known as BENEFIT-ALS (Blinded Evaluation of Neuromuscular Effects and Functional Improvement with Tirasemtiv in ALS). Another Phase II clinical trial, known as COSMIC-HF (Chronic Oral Study of Myosin Activation to Increase Contractility in Heart Failure), is currently being conducted.
Cytokinetics and the Japan-based Astellas Pharma Inc. (ALPMF) are collaborating to advance novel therapies for diseases and medical conditions associated with muscle weakness. The company is also collaborating with Amgen (AMGN) to discover, develop, and commercialize novel small-molecule therapeutics that activate cardiac muscle contractility for potential applications in the treatment of heart failure. Omecamtiv mecarbil is the most advanced drug candidate in this collaboration.
In September 2013, Cytokinetics’ stock fell after it said its ATOMIC-AHF (Acute Treatment with Omecamtiv Mecarbil to Increase Contractility in Acute Heart Failure) study didn’t meet its primary endpoint of dyspnea (shortness of breath) response. However, partner Amgen said it would continue evaluating the oral formulations of omecamtiv mecarbil.
The company’s fourth quarter results beat analyst expectations. Total revenues were $24.3 million for the fourth quarter of 2013, compared to $2.2 million during the same period in 2012. Net income for the fourth quarter was $6.5 million, or $0.21 per diluted share, compared to a net loss for the same period in 2012, of -$11.5 million, or -$0.48 per diluted share. The company announced significant progress in both its BENEFIT-ALS and COSMIC-HF clinical development programs. Total revenue for full year 2013 was $30.6 million, compared to $7.6 million for the same period in 2012.
Revenues for the fourth quarter of 2013 included $2.4 million of license revenues and $4.1 million of research and development revenues from its collaboration with Astellas and $17.2 million of license revenues and $0.6 million of research and development revenues from its collaboration with Amgen.
The company anticipates cash revenue will be in the range of $19 to $21 million for 2014.
Cytokinetics said in its filing that if tirasemtiv is approved for marketing by the FDA or other regulatory authorities for the treatment of ALS, it may then compete with other potential new therapies for ALS that are currently being developed by companies such as Mitsubishi Tanabe Pharma Corporation (MTZPY), Eisai Inc. (ESALF), Trophos SA, Neuraltus Pharmaceuticals, Inc., Isis Pharmaceuticals, Inc. (ISIS), and GlaxoSmithKline plc (GSK).
Plus, BrainStorm Cell Therapeutics (BCLI) and Neuralstem (CUR) are each conducting clinical development of stem cell therapies for the potential treatment of ALS. Novartis (NVS), in collaboration with Morphosys AG, is conducting clinical development with an activin type-IIB receptor antagonist, bimagrumab, to evaluate its ability to treat diseases involving the loss of muscle mass, strength, and function.