Intra-Cellular Therapies Reports Fourth Quarter and Full-Year 2017 Financial Results and Provides Corporate Update
Selected Fourth Quarter and Year End 2017 Financial Results
Research and development (R&D) expenses for the fourth quarter of 2017 were
General and administrative (G&A) expenses were
Cash, cash equivalents and investment securities totaled
The Company expects that its cash, cash equivalents and investment securities of
- 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 FDAis scheduled to be held in late Q1 2018.
November 2017, we announced that the FDAhas 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.
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.
- 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 Statesand 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.
- 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
- 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.
- 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, 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.
Conference Call and Webcast Details
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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 an 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 availability of data from our ongoing Phase 3 trials in bipolar depression and agitation associated with dementia, including Alzheimer’s disease, and our expectations about the timing of our NDA filing for bipolar depression; our plans and the expected timing to initiate a late stage program in depression; our development plans for our PDE program, including ITI-214, including the anticipated timing for the availability of data from our ongoing Phase 1/2 trial of ITI-214 and the expected timing of the initiation of a trial of ITI-214 in patients with systolic heart failure; our development plans for our ITI-333 program 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; 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 December 31,||Twelve Months Ended December 31,|
|Costs and expenses:|
|Research and development||26,929,041||21,179,010||79,419,009||93,831,530|
|General and administrative||5,784,278||6,951,498||23,666,957||24,758,063|
|Total costs and expenses||32,713,319||28,130,508||103,085,966||118,589,593|
|Loss from operations||(32,708,264||)||(28,032,613||)||(102,840,129||)||(118,258,891||)|
|Income tax (benefit) expense||(1,058,435||)||233,055||(1,060,851||)||1,065,673|
|Net loss per common share:|
|Basic & Diluted||$||(0.56||)||$||(0.64||)||$||(2.12||)||$||(2.69||)|
|Weighted average number of common shares:|
|Basic & Diluted||54,407,104||43,272,233||46,181,926||43,240,188|
|(1) The condensed consolidated statements of operations for the years ended December 31, 2017 and 2016 have been derived from the financial statements but do not include all of the information and footnotes required by accounting principles generally accepted in the United States for complete financial statements.|
|INTRA-CELLULAR THERAPIES, INC.|
|CONDENSED CONSOLIDATED BALANCE SHEETS|
|Cash and cash equivalents||$||37,790,114||$||48,642,225|
|Investment securities, available-for-sale||426,540,921||335,458,459|
|Prepaid expenses and other current assets||4,884,293||4,005,093|
|Total current assets||469,215,328||388,200,116|
|Property and equipment, net||1,137,171||627,614|
|Long term deferred tax asset, net||1,058,435||—|
|Liabilities and stockholders’ equity|
|Accrued and other current liabilities||6,424,221||5,329,293|
|Accrued employee benefits||1,611,846||1,448,394|
|Total current liabilities||14,209,606||10,532,334|
|Long-term deferred rent||2,840,132||2,868,622|
|Common stock, $.0001 par value: 100,000,000 shares authorized; 54,597,679 and 43,292,906 shares issued and outstanding at December 31, 2017 and December 31, 2016, respectively||5,460||4,329|
|Additional paid-in capital||862,479,505||685,290,815|
|Accumulated comprehensive loss||(799,224||)||(317,239||)|
|Total stockholders’ equity||454,436,961||375,502,539|
|Total liabilities and stockholders’ equity||$||471,486,699||$||388,903,495|
|(1) The condensed consolidated balance sheets at December 31, 2017 and 2016 have been derived from the financial statements but do not include all of the information and footnotes required by accounting principles generally accepted in the United States for complete financial statements.
Source: Intra-Cellular Therapies Inc.