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May 25, 2015 4:22 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. Presents Analyses of the Phase 2 Clinical Trial of ITI-007 in Schizophrenia At the American Psychiatric Association

Intra-Cellular Therapies, Inc. focused on the development of therapeutics for central nervous system (CNS) disorders presented further analyses of the Phase 2 clinical trial of ITI-007 in schizophrenia at the American Psychiatric Association (APA) 168th Annual Meeting being held in Toronto, Canada. The oral presentation titled ITI-007 for the Treatment of Schizophrenia: Further Analyses of the Randomized ITI-007-005 Trial was presented by Kimberly E. Vanover, Ph.D., Vice President of Clinical Development. The presentation provided further analyses of the Phase 2 clinical trial of ITI-007, whose topline results and secondary analyses were previously presented at scientific and medical meetings. As previously reported, ITI-007 at a dose of 60 mg demonstrated a statistically significant improvement in psychosis on the trial's pre-specified primary endpoint, which was a change from baseline on the PANSS total score, compared to placebo on Study day 28 (p = 0.017; MMRM-ITT). At 60 mg, ITI-007 demonstrated a differentiated efficacy response profile including improvements in negative symptoms, depression and prosocial behavior. Specifically, 60 mg ITI-007 improved negative symptoms in both the overall intent-to-treat (ITT) population and in the pre-specified subgroup of patients with prominent negative symptoms at baseline. These effects were not seen with risperidone. In a subgroup of schizophrenia patients who had co-morbid depression, ITI-007 60mg showed a rapid, robust and statistically significant anti-psychotic effect not observed with risperidone. Furthermore, ITI-007 60mg consistently and significantly improved depressive symptoms in this subgroup. The Phase 2 clinical trial, ITI-007-005, was a randomized, double-blind, placebo- and active-controlled clinical trial in patients with an acutely exacerbated episode of schizophrenia. In this trial, 335 patients were randomized to receive one of four treatments: 60 mg ITI-007, 120 mg ITI-007, 4 mg risperidone (active control) or placebo in a 1:1:1:1 ratio. Patients received study treatment orally once daily in the morning for 28 days. Of those randomized, 311 patients were included in the ITT primary analysis. The primary endpoint for this clinical trial was change from baseline to Day 28 on the PANSS total score. The PANSS is a well-validated, 30-item rating scale that measures the ability of a drug to reduce schizophrenia symptom severity (Kay et al., 1987, Schizophrenia Bulletin 13:261-276). The PANSS measures positive symptoms such as delusions, suspiciousness, and hallucinations; negative symptoms, such as blunted affect, social and emotional withdrawal, and stereotyped thinking; and general psychopathology, such as anxiety, tension, depression, and active social avoidance. Safety and tolerability were also assessed.

Intra-Cellular Therapies, Inc. Presents at Bank of America Merrill Lynch 2015 Health Care Conference, May-14-2015 08:40 AM

Intra-Cellular Therapies, Inc. Presents at Bank of America Merrill Lynch 2015 Health Care Conference, May-14-2015 08:40 AM. Venue: Encore at the Wynn, 3131 S Las Vegas Blvd, Las Vegas, Nevada, United States. Speakers: Sharon Mates, Co-Founder, Chairman, Chief Executive Officer and President.

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.

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