NEW YORK, Aug. 02, 2018 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (Nasdaq: ITCI), a biopharmaceutical company focused on the development of therapeutics for central nervous system (CNS) disorders, today provided a corporate update and announced its financial results for the second quarter ended June 30, 2018.
“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. Sharon Mates, Chairman and CEO of ITCI. “We are excited about our prospects for the remainder of the year as we expect to complete our New Drug Application (NDA) submission shortly for lumateperone for the treatment of schizophrenia, announce top-line results from our first Phase 3 study in bipolar depression, conduct an interim analysis on our Phase 3 study in agitation in patients with dementia, including Alzheimer’s disease, and present results from our ITI-214 study in patients with Parkinson’s disease (PD).”
Corporate Update
Lumateperone Programs
ITI-214 (PDE1 inhibitor) Programs
Parkinson’s Disease (PD)
Heart Failure
ITI-333 Program
Second Quarter 2018 Financial Results
The Company reported a net loss of $37.4 million, or $0.68 per share (basic and diluted), for the second quarter of 2018 compared to a net loss of $17.8 million, or $0.41 per share (basic and diluted), for the second quarter of 2017.
Research and development (R&D) expenses for the second quarter of 2018 were $32.4 million, compared to $12.5 million for the second quarter of 2017. The increase for the second quarter of 2018 is primarily due to an increase of approximately $18.7 million of external clinical and non-clinical costs. In the second quarter of 2018, external costs were incurred for the Phase 3 clinical trials of lumateperone in patients with bipolar depression and in patients with agitation associated with dementia, including Alzheimer’s disease, and other lumateperone related trials and manufacturing, development and clinical costs for our phosphodiesterase (PDE) program. In the second quarter of 2017, external costs were incurred primarily for the Phase 3 clinical trials of lumateperone in patients with bipolar depression and in patients with agitation associated with dementia, including Alzheimer’s disease, and other lumateperone related trials.
General and administrative (G&A) expenses were $6.7 million for the second quarter of 2018, compared to $6.3 million for the same period in 2017. The comparative increase is primarily due to labor and pre-commercialization costs, partially offset by lower stock compensation expense and professional fees.
Cash, cash equivalents, and investment securities totaled $403.8 million at June 30, 2018, compared to $464.3 million at December 31, 2017.
The Company expects that its cash, cash equivalents, and investment securities of $403.8 million as of June 30, 2018 will be used primarily to advance the lumateperone development program, including to fund clinical trials of lumateperone in patients with bipolar depression, in patients with agitation associated with dementia, including Alzheimer’s disease, 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 agitation associated with dementia, including Alzheimer’s disease; to fund preclinical and clinical development of the Company’s ITI-007 long-acting injectable program; to fund non-clinical activities, including the continuation of manufacturing activities, in connection with the development of lumateperone; and to fund other clinical and preclinical programs, including the Company’s PDE development activities including ITI-214, for the treatment of PD, heart failure and other disorders.
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.
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 and for the treatment of heart failure.
Forward-Looking Statements
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 FDA; our reliance on collaborative partners and other third parties for development of our product candidates; and the other risk factors detailed in our public filings with the Securities and Exchange Commission. All statements contained in this press release are made only as of the date of this press release, and we do not intend to update this information unless required by law.
Contact:
Intra-Cellular Therapies, Inc.
Juan Sanchez, M.D.
Vice President, Corporate Communications and Investor Relations
646-440-9333
Burns McClellan, Inc.
Lisa Burns
lburns@burnsmc.com
212-213-0006
INTRA-CELLULAR THERAPIES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
Three Months Ended June 30, | ||||||
2018 (1) | 2017 (1) | |||||
Revenues | $ | — | $ | 114,741 | ||
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 | ) | ||
Interest income | 1,793,474 | 857,809 | ||||
Loss before provision for income taxes | (37,374,783 | ) | (17,760,704 | ) | ||
Income tax expense | 1,600 | — | ||||
Net loss | $ | (37,376,383 | ) | $ | (17,760,704 | ) |
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 June 30, 2018 and 2017 have not been audited and 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
June 30, 2018 (1) | December 31, 2017 (1) | |||||
(Unaudited) | (Audited) | |||||
Assets | ||||||
Current assets: | ||||||
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 | ||||
Other assets | 78,833 | 75,765 | ||||
Total assets | $ | 412,073,723 | $ | 471,486,699 | ||
Liabilities and stockholders’ equity | ||||||
Current liabilities: | ||||||
Accounts payable | 5,378,870 | 6,173,539 | ||||
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 | ||||
Total liabilities | 21,686,281 | 17,049,738 | ||||
Stockholders’ equity: | ||||||
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 deficit | (480,105,241 | ) | (407,248,780 | ) | ||
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 June 30, 2018 and December 31, 2017 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.