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May 05, 2015 1:29 AM ET

Pharmaceuticals

Company Overview of Intra-Cellular Therapies, Inc.

Company Overview

Intra-Cellular Therapies, Inc., a biopharmaceutical company, discovers and develops small molecule drugs for the treatment of neuropsychiatric and neurologic disorders within the central nervous system (CNS). Its lead drug candidate is ITI-007, which is in phase III clinical development for the treatment of schizophrenia, behavioral disturbances in dementia, bipolar disorder, depression, and other neuropsychiatric and neurological disorders. The company also develops ITI-002 program that is in phase 1 development for the treatment of central nervous system, cardiovascular, and other disorders. Intra-Cellular Therapies, Inc. has a license and collaboration agreement with Takeda Pharmaceutical...

430 East 29th Street

New York, NY 10016

United States

25 Employees

Phone:

212-923-3344

Key Executives for Intra-Cellular Therapies, Inc.

Co-Founder, Chairman, Chief Executive Officer and President
Age: 61
Total Annual Compensation: $954.0K
Co-Founder and Vice President of Business Development
Age: 54
Total Annual Compensation: $283.7K
Chief Financial Officer, Vice President of Finance, Treasurer and Assistant Secretary
Age: 58
Total Annual Compensation: $386.3K
Senior Vice President, General Counsel and Secretary
Age: 41
Total Annual Compensation: $207.5K
Vice President of Corporate Communications & Investor Relations
Age: 43
Total Annual Compensation: $294.4K
Compensation as of Fiscal Year 2014.

Intra-Cellular Therapies, Inc. Key Developments

Intra-Cellular Therapies, Inc. Reports Unaudited Consolidated Earnings Results for the First Quarter Ended March 31, 2015

Intra-Cellular Therapies, Inc. reported unaudited consolidated earnings results for the first quarter ended March 31, 2015. For the quarter, the company reported a net loss of $22,286,824, or $0.72 per basic and diluted share, compared with a net loss of $4,543,284 or $0.17 per basic and diluted share a year ago. Revenues were $3,315 against $167,787 a year ago. Loss from operations was $22,400,740 against $4,574,463 a year ago. Research and development (R&D) expenses were $18.6 million, compared to $2.8 million for the first quarter of 2014. The increase is due primarily to costs associated with program ITI-007 Phase 3 clinical trial which was initiated in late 2014.

Intra-Cellular Therapies, Inc., Q1 2015 Earnings Call, Apr 30, 2015

Intra-Cellular Therapies, Inc., Q1 2015 Earnings Call, Apr 30, 2015

Intra-Cellular Therapies Presents the ITI-007 Clinical Development Program at the 15th International Congress on Schizophrenia Research

Intra-Cellular Therapies, Inc. presented data regarding the ITI-007 development program and described the rationale supporting the strategy for the advancement of ITI-007 in multiple clinical indications at the 15th International Congress on Schizophrenia Research (ICOSR) in Colorado Springs. In a poster the company described the rationale for dose selection in the ongoing Phase 3 clinical trial in schizophrenia. Preclinical data predicted antipsychotic efficacy at human equivalent doses as low as 20 – 40 mg of ITI-007. Positron emission tomography (PET) data in healthy volunteers demonstrated striatal D2 receptor occupancy of ~20% and ~40% at doses of 20 mg and 40 mg, respectively. Striatal D2 receptor occupancy at 60 mg was projected to be approximately 50%. In a Phase 2 clinical trial in patients with schizophrenia, ITI-007 at a dose of 60 mg demonstrated a statistically significant and clinically meaningful improvement in psychosis with a favorable metabolic, cardiovascular and motor adverse event profile. Based on the preclinical and clinical results described above the company selected doses of 60 mg and 40 mg of ITI-007 for the ongoing Phase 3 clinical trial in schizophrenia. This study, ITI-007-301, is a randomized, double-blind, placebo-controlled, inpatient clinical trial in patients with an acutely exacerbated episode of schizophrenia. In this trial, over 400 patients are expected to be randomized to receive one of three treatments: 60 mg ITI-007, 40 mg ITI-007 or placebo in a 1:1:1 ratio. The company anticipates topline results from this trial will be available in the second half of 2015. In an oral presentation the company summarized the clinical progress of ITI-007 to date and emphasized its rationale supporting the development of ITI-007 for other indications. ITI-007 has a unique pharmacological profile acting as a serotonergic, dopaminergic, and glutamatergic modulator. In addition, ITI-007 has a dose-dependent pharmacology. At low doses, ITI-007 acts mainly as a potent 5-HT2A receptor antagonist, with modest interaction with other drug targets. As the dose is increased, additional pharmacological interactions play a greater role, i.e., dopamine and glutamate receptor modulation and inhibition of SERT are gradually increased. The company emphasized the pharmacological, pharmacodynamic and safety profile of ITI-007, which supports its development in other indications beyond schizophrenia, including bipolar disorder and major depressive disorder as well as behavioral disturbances in patients with dementia.

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