Intra-Cellular Therapies Provides Corporate Update and Reports Second Quarter 2018 Financial Results
“In the first half of 2018, we made great progress advancing our development programs and as we continue to build our team, we are pleased with the progress we have made in our activities to prepare for the commercialization of lumateperone,” said Dr.
- In the second quarter of 2018, we announced the initiation of a rolling submission of our NDA with the U.S. Food and Drug Administration (
FDA) for lumateperone for the treatment of schizophrenia. We expect to complete this NDA submission mid-2018, in the third quarter.
- We presented data on lumateperone and other development programs at several scientific and medical conferences, including the
American Psychiatric Association(APA), the Society of Biological Psychiatry(SOBP), the American Society of Clinical Psychopharmacology(ASCP), and the International College of Neuropsychopharmacology(CINP).
- At ASCP, we presented data highlighting symptom improvement by lumateperone on negative symptoms, depression, and social function in patients with schizophrenia. One of our presentations at ASCP focused on the effect of lumateperone on a specific domain of negative symptoms of schizophrenia known to correlate with social function. The other presentation addressed the potential of lumateperone to improve symptoms of depression in patients with schizophrenia. These presentations build on prior data and continue to support our belief that the unique pharmacology of lumateperone can translate into an advancement in the treatment of schizophrenia.
- Later this year, we will be presenting results from the second part of our lumateperone open-label safety switching study. To assess long-term safety and to observe the impact of switching from standard-of-care antipsychotic medications, we are conducting an open-label safety switching study in stable patients with schizophrenia switched to lumateperone (ITI-007 60 mg) from standard-of-care antipsychotic therapy. This study has two parts. Positive results from the first part were reported last year for patients who were switched to a 6-week treatment duration with lumateperone followed by a 2-week period in which they were switched back to standard-of-care. The second part of the study, our long-term safety study in schizophrenia, follows patients for up to 1-year of treatment with lumateperone following switch from standard-of-care.
- We continue to advance our lumateperone bipolar depression Phase 3 clinical program. This program consists of two monotherapy studies and one adjunctive study. We anticipate top-line results from the first monotherapy study (Study 401) 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 submit an NDA for bipolar depression in 2H 2019. Our adjunctive study (Study 402), which is being conducted globally, is ongoing.
- Our lumateperone program in patients with 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.
- We plan to initiate our clinical program of lumateperone in depressive disorders in 2H 2018.
ITI-214 (PDE1 inhibitor) Programs
Parkinson’s Disease (PD)
- We continue to advance our Phase 1/2 randomized, double-blind, placebo-controlled, multiple ascending dose clinical trial to evaluate ITI-214, our PDE1 inhibitor, in patients with PD. The primary objective is to evaluate the safety and tolerability of ITI-214 in patients with mild to moderate PD. 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 explored. Clinical conduct has been completed for the first four cohorts (1, 3, 10 and 30 mg). At these doses, ITI-214 demonstrated a favorable safety profile and was generally well tolerated. Based on this favorable safety and tolerability profile, the study has been expanded to include a higher dose cohort (90 mg) and clinical conduct is ongoing. We plan to present results from this trial later this year.
- The journal Circulation recently published online a paper entitled “Acute Enhancement of Cardiac Function by Phosphodiesterase Type 1 Inhibition: A Translational Study in the Dog and Rabbit” highlighting ITI-214’s novel mechanism of action in heart failure and demonstrating positive results in animal models of heart failure. The data published in Circulation indicates ITI-214 acts by a novel mechanism of action via modulation of the adenosine A2B receptor signaling pathway and increases cardiac contractility without increasing intracellular calcium. The pharmacological profile of ITI-214 introduces a new mechanism of action for the treatment of heart failure that is different from ß-adrenergic agonism and PDE3 inhibition and offers a potential new treatment for heart failure with a novel mechanism of action that may provide an effective and safer alternative to existing therapies.
- We have initiated our ITI-214 program for the treatment of heart failure. Clinical conduct is ongoing in a randomized, double-blind, placebo-controlled study of escalating single doses of ITI-214 to evaluate hemodynamic effects and safety in patients with systolic heart failure.
- ITI-333, our novel, oral modulator of serotonin, dopamine, and mu opiate receptors continues to advance in preclinical development. We plan to develop ITI-333 for the treatment of opioid and other substance use disorders, pain, and mood disorders. We expect to initiate clinical trials in 2019.
Second Quarter 2018 Financial Results
The Company reported a net loss of
Research and development (R&D) expenses for the second quarter of 2018 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
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 4697699. 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 an NDA submission for lumateperone for the treatment of schizophrenia and our expectations about the timing of completing such NDA submission; 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 submission for bipolar depression; the expected timing for conducting an interim analysis of the Phase 3 trial in agitation in patients with dementia, including Alzheimer’s disease, and the expected timing for the availability of the outcome of this analysis; our plans and the expected timing to initiate a program in depression; the expected timing for the availability of data from the second part of our lumateperone open-label safety switching study; our expectations about presenting additional data at upcoming scientific and medical conferences; 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 in patients with PD; our development plans for our ITI-333 program and our expected timing of the initiation of clinical trials for ITI-333 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
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
|Three Months Ended June 30,|
|Costs and expenses:|
|Research and development||32,439,270||12,478,638|
|General and administrative||6,728,987||6,254,616|
|Total costs and expenses||39,168,257||18,733,254|
|Loss from operations||(39,168,257||)||(18,618,513||)|
|Loss before provision for income taxes||(37,374,783||)||(17,760,704||)|
|Income tax expense||1,600||—|
|Net loss per common share:|
|Basic & Diluted||$||(0.68||)||$||(0.41||)|
|Weighted average number of common shares:|
|Basic & Diluted||54,696,698||43,419,798|
(1) The condensed consolidated statements of operations for the quarters ended
INTRA-CELLULAR THERAPIES, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
|Cash and cash equivalents||$||69,767,045||$||37,790,114|
|Investment securities, available-for-sale||333,997,440||426,540,921|
|Prepaid expenses and other current assets||5,896,583||4,884,293|
|Total current assets||409,661,068||469,215,328|
|Property and equipment, net||1,275,387||1,137,171|
|Long term deferred tax asset, net||1,058,435||1,058,435|
|Liabilities and stockholders’ equity|
|Accrued and other current liabilities||10,462,217||6,424,221|
|Accrued employee benefits||3,094,280||1,611,846|
|Total current liabilities||18,935,367||14,209,606|
|Long-term deferred rent||2,750,914||2,840,132|
|Common stock, $.0001 par value: 100,000,000 shares authorized; 54,700,580 and 54,597,679 shares issued and outstanding at June 30, 2018 and December 31, 2017, respectively||5,470||5,460|
|Additional paid-in capital||871,516,637||862,479,505|
|Accumulated comprehensive loss||(1,029,424||)||(799,224||)|
|Total stockholders’ equity||390,387,442||454,436,961|
|Total liabilities and stockholders’ equity||$||412,073,723||$||471,486,699|
(1) The condensed consolidated balance sheets at
Source: Intra-Cellular Therapies Inc.