Intra-Cellular Therapies Provides Corporate Update and Reports Second Quarter 2019 Financial Results
“We continue to advance our lumateperone schizophrenia program and prepare for commercial launch pending
- Our new drug application (NDA) for lumateperone, an investigational agent for the treatment of schizophrenia, is under review by the U.S. Food and Drug Administration (
FDA). We recently met with the FDAand reached agreement to submit additional non-clinical information in connection with the FDA’s ongoing review of our NDA for lumateperone for the treatment of schizophrenia. The FDAhas informed us that the planned submission of this additional information constitutes a major amendment to the NDA, resulting in a three-month extension of the Prescription Drug User Fee Act (PDUFA) goal date to December 27, 2019in order to provide time for a full review of the submission. We intend to provide the FDAwith the requested information in the coming weeks and we believe this information will be sufficient to address the FDA’s requests.
- We continue to make substantial progress in establishing our commercial capabilities and infrastructure to support the potential launch of lumateperone in the first quarter of 2020, pending timely
FDAapproval of the NDA. All manufacturing and supply chain related activities remain on track to support commercial supply. Our build-out of sales, marketing and managed care functions to support commercial operations and launch are also on track.
- At the 2019 American Psychiatric Association (APA) annual meeting, we presented posters highlighting lumateperone’s favorable safety and tolerability profile in schizophrenia clinical studies. In addition, we successfully launched our disease awareness campaign to highlight the significant unmet medical needs that remain in the treatment of schizophrenia.
- We presented positive topline results in our bipolar depression program from Study ‘404, a Phase 3 trial of lumateperone in patients with bipolar depression. Study 404 met its primary endpoint of change from baseline at Week 6 on the Montgomery-Åsberg Depression Rating Scale (MADRS) total score versus placebo (p<0.001; effect size = 0.56). These benefits were statistically significant in both Bipolar I and Bipolar II patients. The study also met its key secondary objective on the Clinical Global Impression Scale for Bipolar for Severity of Illness (CGI-BP-S) Total Score (p<0.001; effect size = 0.46); lumateperone was also positive on the CGI component that specifically assesses depression (CGI-BP-S Depression Score; p<0.001; effect size = 0.50). In a second Phase 3 trial, Study ‘401, lumateperone did not separate from placebo. A high placebo response was observed in the trial. In both trials, lumateperone demonstrated a favorable safety profile and was generally well-tolerated. Importantly, the rates of akathisia, restlessness and extrapyramidal symptoms combined were less than 1% and similar to placebo in both studies. This safety profile is consistent with previous studies in patients with schizophrenia and provides further evidence supporting lumateperone’s favorable safety and tolerability profile across different patient populations. We plan to present additional details at upcoming medical conferences later this year. Our global adjunctive bipolar depression study, Study ‘402, is ongoing.
Major Depressive Disorder
- We believe lumateperone has the potential to exhibit potent and rapid antidepressant effects and have an ongoing program in major depressive disorder. In order to explore the effect of different modes of drug administration and the potential for rapid-onset antidepressant activity, our program includes the assessment of novel formulations of lumateperone. We are continuing to explore the pharmacokinetics of these formulations.
- Our randomized, double-blind, placebo-controlled study of escalating single doses of ITI-214, our phosphodiesterase 1 (PDE1) inhibitor, to evaluate hemodynamic effects and safety in patients with systolic heart failure is ongoing. Clinical conduct for the second cohort, 30 mg, is ongoing following completion of the 10 mg dose cohort where no safety concerns were identified. In addition, we are evaluating a Phase 2, proof-of-concept clinical trial of ITI-214 for the treatment of Parkinson’s disease. We are also exploring ITI-214 and other PDE1 inhibitors in other CNS and non-CNS indication.
- We plan to develop ITI-333, our novel, oral modulator of serotonin, dopamine, and mu opioid receptors, for the treatment of opioid and other substance use disorders, pain, and mood disorders. We expect to initiate our clinical program in late 2019 or early 2020.
Selected Second Quarter 2019 Financial Results
Research and development (R&D) expenses for the second quarter of 2019 were
General and administrative (G&A) expenses were
Cash, cash equivalents and investment securities totaled
We expect these existing funds will be used primarily for pre-commercialization activities, initial commercialization activities and related infrastructure expansion in connection with the commercialization of lumateperone, if approved, for the treatment of schizophrenia; the development of lumateperone in our late stage clinical programs; the development of our other product candidates, including ITI-214; the continuation of manufacturing activities in connection with the development of lumateperone; and general operations.
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 is under review by the FDA for the treatment of schizophrenia and is in Phase 3 clinical development for the treatment of bipolar depression. 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.
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; the safety, tolerability and efficacy of our product candidates; our intent to provide the
Vice President, Corporate Communications and Investor Relations
Corporate Media Relations, W2Owcg
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
|Three Months Ended June 30,|
|2019 (1)||2018 (1)|
|Costs and expenses:|
|Research and development||23,728,464||32,439,270|
|General and administrative||15,442,650||6,728,987|
|Total costs and expenses||39,171,114||39,168,257|
|Loss from operations||(39,171,114||)||(39,168,257||)|
|Loss before provision for income taxes||(37,439,564||)||(37,374,783||)|
|Income tax expense||1,600||1,600|
|Net loss per common share:|
|Basic & Diluted||$||(0.68||)||$||(0.68||)|
|Weighted average number of common shares:|
|Basic & Diluted||55,145,901||54,696,698|
(1) The condensed consolidated statements of operations for the quarters ended
June 30, 2019and 2018 have not been audited and do not include all of the information and footnotes required by accounting principles generally accepted in the United Statesfor complete financial statements.
INTRA-CELLULAR THERAPIES, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
|Cash and cash equivalents||$||91,763,368||$||54,947,502|
|Investment securities, available-for-sale||193,536,800||292,583,046|
|Prepaid expenses and other current assets||3,041,730||7,908,133|
|Total current assets||288,341,898||355,438,681|
|Property and equipment, net||2,082,933||1,159,766|
|Right of use assets, net||18,822,482||—|
|Deferred tax asset, net||529,218||529,218|
|Liabilities and stockholders’ equity|
|Accrued and other current liabilities||18,801,485||20,044,866|
|Lease liabilities, short-term||2,262,977||—|
|Accrued employee benefits||5,829,242||2,293,259|
|Total current liabilities||32,526,487||36,299,185|
|Common stock, $0.0001 par value: 100,000,000 shares authorized; 55,186,745 and 54,895,295 shares issued and outstanding at June 30, 2019 and December 31, 2018, respectively||5,519||5,490|
|Additional paid-in capital||891,183,518||880,753,339|
|Accumulated comprehensive gain/(loss)||232,444||(667,757||)|
|Total stockholders’ equity||256,768,362||317,714,881|
|Total liabilities and stockholders’ equity||$||309,862,614||$||357,206,498|
(1) The condensed consolidated balance sheets at
June 30, 2019and December 31, 2018have 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.