ITCI Reports 4th Quarter & Year-End 2017 Results. Stock down almost 10% at one point this morning. I don't see the reason for the drop. Comments?
Intra-Cellular Therapies Reports Fourth Quarter and Full-Year 2017 Financial Results and Provides Corporate Update
GlobeNewswire•March 1, 2018
NEW YORK, March 01, 2018 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (ITCI), a biopharmaceutical company focused on the development of therapeutics for central nervous system (CNS) disorders, today announced its financial results for the fourth quarter and year ended December 31, 2017, and provided a corporate update.
Selected Fourth Quarter and Year End 2017 Financial Results
Intra-Cellular Therapies (the Company or ITCI) reported a net loss of $30.2 million, or $0.56 per share (basic and diluted), for the fourth quarter of 2017 compared to a net loss of $27.5 million, or $0.64 per share (basic and diluted), for the fourth quarter of 2016. The Company reported a net loss of $97.8 million, or $2.12 per share (basic and diluted), for the full year ended December 31, 2017 compared with a net loss of $116.4 million, or $2.69 per share (basic and diluted), for the full year ended December 31, 2016.
Research and development (R&D) expenses for the fourth quarter of 2017 were $26.9 million, compared to $21.2 million for the fourth quarter of 2016. The $5.7 million increase is primarily due to higher clinical trial related costs in the fourth quarter of 2017. Research and development expenses for the year ended December 31, 2017 were $79.4 million, compared to $93.8 million for the year ended December 31, 2016. The decrease of $14.4 million is primarily due to lower clinical trials related costs and, to a lesser degree, lower non-clinical and manufacturing costs, offset in part by an increase in labor related costs, in 2017.
General and administrative (G&A) expenses were $5.8 million for the fourth quarter of 2017, compared to $7.0 million for the same period in 2016. The decrease of $1.2 million is due primarily to lower marketing and consulting costs and lower stock compensation expense in the fourth quarter of 2017. General and administrative expenses for the year ended December 31, 2017 were $23.7 million, compared to $24.8 million for the year ended December 31, 2016. The decrease of $1.1 million is primarily due to lower marketing and consulting costs, offset in part by higher capital tax expense, in 2017.
Cash, cash equivalents and investment securities totaled $464.3 million at December 31, 2017, compared to $384.1 million at December 31, 2016. In October 2017, the Company raised gross proceeds of approximately $172 million, with net proceeds of $162 million, in a public offering of its common stock.
The Company expects that its cash, cash equivalents and investment securities of $464.3 million as of December 31, 2017 will be used primarily to advance the lumateperone development program, including to fund clinical trials of lumateperone in bipolar depression, behavioral disturbances in patients with dementia, depressive disorders and other lumateperone clinical trials and related clinical and non-clinical activities; to fund pre-commercial activities for lumateperone for the treatment of schizophrenia and bipolar disorder and, if lumateperone receives regulatory approval, initial commercialization efforts; to fund pre-commercial activities for lumateperone for the treatment of behavioral disturbances in patients with dementia, including Alzheimer’s disease; to fund pre-clinical and clinical development of the Company’s ITI-007 long-acting injectable program; and to fund non-clinical activities, including the continuation of manufacturing activities, in connection with the development of lumateperone. The Company expects funds will also be used for other clinical and pre-clinical programs, including the Company’s phosphodiesterase (PDE) development activities.
Corporate Update
Lumateperone Programs
Schizophrenia
Following guidance received from the U.S. Food and Drug Administration (FDA) in 2017, we intend to submit a new drug application (NDA) for lumateperone for the treatment of schizophrenia by mid-2018. A pre-NDA meeting with the FDA is scheduled to be held in late Q1 2018.
In November 2017, we announced that the FDA has granted Fast Track designation for lumateperone for the treatment of schizophrenia. We requested Fast Track designation for lumateperone based on clinical evidence that lumateperone has the potential to address the unmet medical need for the treatment of schizophrenia with significant improvements on several clinically significant safety parameters, including metabolic, motor and cardiovascular issues associated with many currently available antipsychotic agents.
In September 2017, we announced positive topline data from our 6-week open-label safety switching study with lumateperone in patients with schizophrenia. This trial evaluated stable patients with schizophrenia in an outpatient setting similar to common clinical practice and assessed both the impact of switching to lumateperone from standard-of-care antipsychotics (SOC) as well as the impact of switching back to SOC from lumateperone. In this trial, statistically significant improvements from SOC were observed in body weight, cardiometabolic and endocrine parameters in patients with stable symptoms of schizophrenia when switched to lumateperone and worsened again when switched back to SOC. These data are consistent with previous study results reflecting a safety profile similar to placebo in placebo-controlled trials with lumateperone in patients with acutely exacerbated schizophrenia and extend this favorable safety profile to this stable patient population. In this study, symptoms of schizophrenia did not worsen upon switch to lumateperone from SOC. Rather, statistically significant improvement from baseline was observed in the Positive and Negative Syndrome Scale (PANSS) mean total score. Notably, greater improvements were observed in subgroups of patients with comorbid symptoms of depression and those with prominent negative symptoms.
Bipolar Depression
Our lumateperone bipolar depression Phase 3 clinical program consists of two monotherapy studies and one adjunctive study. We anticipate top-line results from the first monotherapy study (Study 401, which is being conducted in the United States) will be available in 2H 2018 and the top-line results from our global monotherapy study (Study 404) will be available in 2019. Subject to the outcomes of these trials, we expect to file an NDA for bipolar depression in 2H 2019. In connection with the global strategy of this program, we are expanding our adjunctive study (Study 402) to clinical sites outside the United States and we expect to provide our anticipated timelines for this study after completing the expansion.
Agitation Associated with Dementia, Including Alzheimer’s Disease
Our lumateperone program in agitation associated with dementia, including Alzheimer’s disease currently consists of one Phase 3 clinical trial and clinical conduct is ongoing. Subject to timely patient enrollment, we expect that the outcome of the interim analysis for this trial will be available in 2H 2018.
Depressive Disorders
In 2017, we presented exciting discoveries demonstrating the molecular mechanism supporting lumateperone’s potential as a rapid acting antidepressant.
In previous studies, schizophrenia patients with co-morbid depression experienced robust improvements in depressive symptoms. We plan to initiate our late stage clinical program of lumateperone in depressive disorders in 2018.
ITI-214 (PDE1 inhibitor) Programs
Parkinson’s Disease
In 2017, we initiated a Phase 1/2 randomized, double-blind, placebo-controlled, multiple rising dose clinical trial to evaluate ITI-214, our PDE1 inhibitor, in patients with Parkinson’s disease (PD). The primary objective is to evaluate the safety and tolerability of ITI-214 in patients with mild to moderate PD who are maintained on stable PD therapy. Secondary objectives are to evaluate the pharmacokinetic profile of ITI-214 and explore its potential utility to control motor fluctuations and to evaluate treatment of non-motor symptoms (daytime sleepiness, dysautonomia) associated with PD. Biomarkers of disease progression (inflammation) will be assessed. Clinical conduct for the third cohort is ongoing following completion of the first and second cohorts, with no safety concerns identified to date. We anticipate top-line results from this trial will be available in 2H 2018.
Heart Failure
In late Q1 2018, we plan to initiate a randomized, double-blind, placebo-controlled study of escalating single doses of ITI-214 to evaluate safety and hemodynamic effects in patients with systolic heart failure.
ITI-333 Program
ITI-333, our novel, oral modulator of serotonin, dopamine, and mu opiate receptors continues to advance in pre-clinical development. We plan to develop ITI-333 for the treatment of opioid and other substance use disorders, pain, and mood disorders.
“We continue to make important progress toward our goal of bringing lumateperone to patients suffering from schizophrenia and other neuropsychiatric disorders. We are excited about our prospects for 2018 and beyond and look forward to providing an update on our programs in the year ahead,” said Dr. Sharon Mates, Chairman and CEO of Intra-Cellular Therapies.
Conference Call and Webcast Details
The Company will host a live conference call and webcast today at 8:30 AM Eastern Time to discuss the Company's financial results and provide a corporate update. The live webcast and subsequent replay may be accessed by visiting the Company's website at www.intracellulartherapies.com. Please connect to the Company's website at least 5-10 minutes prior to the live webcast to ensure adequate time for any necessary software download. Alternatively, please call 1-(844) 835-6563 (U.S.) or 1-(970) 315-3916 (international) to listen to the live conference call. The conference ID number for the live call is 7971178. Please dial in approximately 10 minutes prior to the call.
About Intra-Cellular Therapies
Intra-Cellular Therapies is developing novel drugs for the treatment of neuropsychiatric and neurodegenerative diseases and diseases of the elderly, including Parkinson's and Alzheimer's disease. The Company is developing its lead drug candidate, lumateperone (also known as ITI-007), for the treatment of schizophrenia, bipolar disorder, behavioral disturbances in patients with dementia, including Alzheimer's disease, depression and other neuropsychiatric and neurological disorders. Lumateperone, a first-in-class molecule, is in Phase 3 clinical development for the treatment of schizophrenia, bipolar depression and agitation associated with dementia, including Alzheimer's disease. The Company is also utilizing its phosphodiesterase (PDE) platform and other proprietary chemistry platforms to develop drugs for the treatment of CNS and other disorders. The lead molecule in the Company's PDE1 portfolio, ITI-214, is in development for the treatment of symptoms associated with Parkinson's disease.
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