Intra-Cellular Therapies Reports Third Quarter 2017 Financial Results and Provides Corporate Update
Third Quarter 2017 Financial Results
Research and development (R&D) expenses for the third quarter of 2017 were
General and administrative (G&A) expenses were
Cash, cash equivalents and investment securities totaled
The Company expects that cash, cash equivalents and investment securities of
- 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 (SOC) antipsychotics as well as the impact of switching back to SOC from lumateperone. Unlike many other antipsychotic drugs, patients were switched from SOC without the need for dose titration for lumateperone; patients received the active dose on the first day of treatment. 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 medication. 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 elevated symptomatology such as those with comorbid symptoms of depression and those with prominent negative symptoms.
- We announced that following
U.S. Food and Drug Administration( FDA) guidance received earlier this year regarding our planned new drug application (NDA), we intend to submit an NDA for lumateperone for the treatment of schizophrenia by mid-2018.
- We continue to advance our Phase 3 programs of lumateperone in bipolar depression and in agitation associated with dementia, including Alzheimer’s disease. Our lumateperone bipolar depression program consists of three Phase 3 clinical trials: a monotherapy study conducted in
the United States, an adjunctive study conducted in the United Statesand a global monotherapy study. We expect to complete patient enrollment in our bipolar studies in 2018.
- We recently 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. We expect to complete patient enrollment in this trial by mid-2018.
“During the past few months, we made significant progress in our mission to provide better treatment options for patients suffering from neuropsychiatric and neurodegenerative conditions,” said Dr.
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 13757899. Please dial in approximately 10 minutes prior to the call.
This news release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. Such forward-looking statements include statements regarding, among other things, our expected use of our cash, cash equivalents and investment securities; our beliefs about the extent to which the results of our clinical trials to date support a new drug application (NDA) filing for lumateperone for the treatment of schizophrenia and our expectations about the timing of such NDA filing; our plans and the expected timing for the completion of enrollment of our ongoing Phase 3 trials in bipolar depression; our development plans for our PDE program, including ITI-214, and our ITI-007 long acting injectable program, including the expected timing for completion of patient enrollment in our Phase 1/2 trial of ITI-214; and development efforts and plans under the caption “About Intra-Cellular Therapies.” All such forward-looking statements are based on management's present expectations and are subject to certain factors, risks and uncertainties that may cause actual results, outcome of events, timing and performance to differ materially from those expressed or implied by such statements. These risks and uncertainties include but are not limited to the following: our current and planned clinical trials, other studies for lumateperone, and our other product candidates may not be successful or may take longer and be more costly than anticipated; if we are unable to complete our long-term safety study or the results of our long-term safety study do not demonstrate the safety and tolerability of long-term use of lumateperone, we would not be able to file an NDA for lumateperone for a chronic condition such as schizophrenia; product candidates that appeared promising in earlier research and clinical trials may not demonstrate safety and/or efficacy in larger-scale or later clinical trials; our proposals with respect to the regulatory path for our product candidates may not be acceptable to the
Vice President, Corporate Communications and Investor Relations
|INTRA-CELLULAR THERAPIES, INC.|
|CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS|
|Three Months Ended September 30,|
|Costs and expenses:|
|Research and development||18,472,372||23,918,232|
|General and administrative||5,317,577||6,270,528|
|Total costs and expenses||23,789,949||30,188,760|
|Loss from operations||(23,759,195||)||(30,184,398||)|
|Loss before provision for income taxes||(22,874,432||)||(29,432,709||)|
|Income tax benefit (expense)||4,016||(832,618||)|
|Net loss per common share:|
|Basic & Diluted||$||(0.53||)||$||(0.70||)|
|Weighted average number of common shares:|
|Basic & Diluted||43,424,387||43,253,429|
(1) The condensed consolidated statements of operations for the quarters ended
|INTRA-CELLULAR THERAPIES, INC.|
|CONDENSED CONSOLIDATED BALANCE SHEETS|
|Cash and cash equivalents||$||52,340,519||$||48,642,225|
|Investment securities, available-for-sale||275,781,285||335,458,459|
|Prepaid expenses and other current assets||5,307,357||4,005,093|
|Total current assets||333,435,470||388,200,116|
|Property and equipment, net||679,606||627,614|
|Liabilities and stockholders’ equity|
|Accrued and other current liabilities||4,151,120||5,329,293|
|Accrued employee benefits||3,316,378||1,448,394|
|Total current liabilities||11,875,153||10,532,334|
|Long-term deferred rent||2,875,612||2,868,622|
|Common stock, $.0001 par value: 100,000,000 shares authorized; 43,427,344 and 43,292,906 shares issued and outstanding at September 30, 2017 and December 31, 2016, respectively||4,342||4,329|
|Additional paid-in capital||696,695,317||685,290,815|
|Accumulated comprehensive loss||(219,515||)||(317,239||)|
|Total stockholders’ equity||319,440,076||375,502,539|
|Total liabilities and stockholders’ equity||$||334,190,841||$||388,903,495|
(1) The condensed consolidated balance sheets at
Source: Intra-Cellular Therapies Inc.