1. Successfully launched CAPLYTA® (lumateperone) in late March 2020 and demonstrated strong commercial execution in the midst of COVID-19.

    CAPLYTA achieved net product revenues of $12.4 million and $22.5 million for fourth quarter and full year 2020, respectively.

    Fourth quarter CAPLYTA total prescriptions (TRx) increased 77% versus the previous quarter.

    Pursuing CAPLYTA label expansion including bipolar depression and major depressive disorder:

    Submitted CAPLYTA supplemental new drug applications (sNDAs) to the FDA for the treatment of bipolar depression in adults as both monotherapy and adjunctive treatment with lithium or valproate.  
     
    Initiated late-stage programs in adjunctive major depressive disorder (MDD) and in patients with bipolar

    Successfully launched CAPLYTA® (lumateperone) in late March 2020 and demonstrated strong commercial execution in the midst of COVID-19.

    CAPLYTA achieved net product revenues of $12.4 million and $22.5 million for fourth quarter and full year 2020, respectively.

    Fourth quarter CAPLYTA total prescriptions (TRx) increased 77% versus the previous quarter.

    Pursuing CAPLYTA label expansion including bipolar depression and major depressive disorder:

    Submitted CAPLYTA supplemental new drug applications (sNDAs) to the FDA for the treatment of bipolar depression in adults as both monotherapy and adjunctive treatment with lithium or valproate.  
     
    Initiated late-stage programs in adjunctive major depressive disorder (MDD) and in patients with bipolar depression and MDD exhibiting mixed features, and advanced the lumateperone long-acting injectable (LLAI) formulation into clinical testing.

    ITI-1284, a new molecular entity:

    Continued pipeline expansion with the introduction of ITI-1284, a deuterated form of lumateperone delivered sublingually as an orally disintegrating tablet.
     
    ITI-1284 has completed Phase I studies and is being developed for behavioral disturbances in dementia, dementia-related psychosis, and certain depressive disorders in the elderly.  

    NEW YORK, Feb. 25, 2021 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (NASDAQ:ITCI), a biopharmaceutical company focused on the development and commercialization of therapeutics for central nervous system (CNS) disorders, today announced its financial results for the fourth quarter ended December 31, 2020, and provided a corporate update.

    "2020 was a transformational year for our company with the launch of our first product, CAPLYTA. I am proud of the important progress that our organization has achieved. We navigated unprecedented and challenging COVID-19 circumstances and still accomplished key commercial and clinical development milestones," said Dr. Sharon Mates, Chairman and CEO of Intra-Cellular Therapies. "We look forward to continuing our progress as we seek to expand our CAPLYTA label to include patients with bipolar depression.  We are excited about our late-stage lumateperone programs in depressive disorders and the advancement of a long-acting injectable formulation into clinical trials as well as further expanding our pipeline with ITI-1284."

    YE 2020 Financial Highlights:

    • Total revenues were $22.8 million for the full year 2020. Net product revenues of CAPLYTA were $22.5 million for the full year 2020. No net product revenues were reported for the comparable periods of 2019.

    • Net loss for the year ended December 31, 2020 was $227.0 million or $3.23 per share (basic and diluted) compared to a net loss of $147.7 million or $2.68 per share (basic and diluted) for the year ended December 31, 2019.

    • Cost of product sales was approximately $1.9 million for the year ended December 31, 2020. Cost of product sales consisted primarily of product royalty fees, overhead and minimal direct costs.

    • Research and development (R&D) expenses for the year ended December 31, 2020 were $65.8 million, compared to $89.1 million for the year ended December 31, 2019, representing a decrease of approximately $23.3 million, or 26%.

    • Selling, general and administrative (SG&A) expenses were $186.4 million for the year ended December 31, 2020, compared to $64.9 million for the year ended December 31, 2019.
      • Selling costs were $132.5 million for the year ended December 31, 2020 as compared to pre-commercialization costs of $32.5 million in the same period in 2019. General and administrative expenses for the year ended December 31, 2020 were $53.9 million, compared to $32.4 million for the same period in 2019.
    • Cash, cash equivalents, restricted cash and investment securities totaled $658.8 million at December 31, 2020, compared to $224.0 million at December 31, 2019.

    Fourth Quarter Financial Highlights:

    • Net product revenues of CAPLYTA were $12.4 million for the fourth quarter of 2020, compared to $7.4 million in net product revenues in the third quarter of 2020.

    • Net loss for the quarter ended December 31, 2020 was $60.7 million compared to a net loss of $40.6 million for the quarter ended December 31, 2019.

    • Research and development (R&D) expenses for the fourth quarter of 2020 were $14.3 million, compared to $19.1 million for the fourth quarter of 2019. This decrease is due primarily to a decrease in manufacturing expense, and a decrease of lumateperone clinical and non-clinical expenses.

    • Selling, general and administrative (SG&A) expenses were $58.3 million for the fourth quarter of 2020, compared to $22.8 million for the same period in 2019. This increase is primarily due to an increase in sales related labor costs and commercialization costs.

    COMMERCIAL HIGHLIGHTS

    • CAPLYTA was launched in late March 2020. Our commercial organization has successfully adapted to the COVID-19 market environment and continues to effectively engage with our prescribing audience through a hybrid model of virtual engagements and in-person interactions, enhanced by an expanded digital marketing initiative.

    • Fourth quarter CAPLYTA results reflect strong commercial execution delivering continued robust prescription growth, increasing total prescriptions 77% versus the third quarter.
    • Established strong CAPLYTA market access coverage with greater than 95% of covered lives in both Medicare Part D and State Medicaid, the major payer channels in schizophrenia. Our LytaLink program continues to be highly competitive and effective in supporting prescribing physicians and eligible patients' access to CAPLYTA.

    2020/2021 CLINICAL HIGHLIGHTS

    Lumateperone - Bipolar Depression Program:

    • We submitted our sNDAs to the FDA for lumateperone as monotherapy and as adjunctive treatment with lithium or valproate for the treatment of depressive episodes associated with bipolar I or II disorder (bipolar depression) in adults. We anticipate an FDA target action date in the second half of 2021.

    • We reported positive topline results from Study ‘402, a global Phase 3 clinical trial evaluating lumateperone as adjunctive therapy to lithium or valproate in the treatment of major depressive episodes associated with Bipolar I or Bipolar II disorder. Lumateperone 42 mg met the primary endpoint for improvement in depression as measured by change from baseline versus placebo on the Montgomery–Åsberg Depression Rating Scale (MADRS) total score. Lumateperone was generally well-tolerated in the trial.

    Other Lumateperone Programs

    • Mixed Features program: Study ‘403 is a large global clinical trial evaluating lumateperone 42 mg in two patient populations: patients with MDD and patients with bipolar depression who exhibit mixed features. The primary endpoint is change from baseline on the MADRS total score at week 6 versus placebo. Results from this study are anticipated in the second half of 2022.

    • Adjunctive MDD program: Commenced a Phase 3 clinical program evaluating lumateperone 42 mg as an adjunctive therapy to antidepressants for the treatment of MDD. Clinical conduct in two studies, Studies ‘501 and ‘502, is anticipated to begin in 2021.

    • Lumateperone Long Acting Injectable (LLAI) formulation: Commenced Study ITI-007-025, a Phase 1 single ascending dose study of LLAI, a formulation designed to be administered subcutaneously and to maintain therapeutic levels of lumateperone for at least one month. Initial results from this study are anticipated in the second half of 2021.

    CAPLYTA- Schizophrenia

    • Recently announced the online publication of "Safety and tolerability of lumateperone 42 mg: An open-label antipsychotic switch study in outpatients with stable schizophrenia" (Correll et al. 2021) in the journal, Schizophrenia Research.  

    Other Programs

    • ITI-1284 program: We recently announced our pipeline expansion with ITI-1284 ODT-SL. ITI-1284 is a deuterated form of lumateperone, a new molecular entity formulated as an orally disintegrating tablet for sublingual administration that has recently completed Phase 1 studies. In these studies, ITI-1284 was generally safe and well-tolerated. We plan to initiate studies evaluating ITI-1284 for the treatment of behavioral disturbances in patients with dementia, the treatment of dementia-related psychosis and the treatment of certain depressive disorders in the elderly.

    • Phosphodiesterase type I inhibitor (PDE1) program: Our PDE1 inhibitor program is focused on diseases in which the PDE1 enzyme is over-expressed and/or abnormal immune cell function contributes to disease pathology providing opportunities to pursue innovative treatments for multiple diseases including Parkinson's, heart failure and other diseases. We have previously reported positive results from Phase 1/2a studies evaluating lenrispodun (ITI-214), our lead molecule, in patients with Parkinson's disease and in patients with chronic systolic heart failure. We plan to advance lenrispodun into a Phase 2 clinical study in Parkinson's disease in 2021.



    • ITI-333 program in opioid use disorder: Commenced Study ITI-333-001, a Phase 1 single ascending dose study evaluating the safety, tolerability and pharmacokinetics of ITI-333 in healthy volunteers. Results from this study are anticipated in the second half of 2021.

    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 8499868. Please dial in approximately 10 minutes prior to the call.

    CAPLYTA® (lumateperone) is indicated for the treatment of schizophrenia in adults. CAPLYTA is available in 42 mg capsules.

    Important Safety Information

    Boxed Warning: Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. CAPLYTA is not approved for the treatment of patients with dementia-related psychosis.

    Contraindications: CAPLYTA is contraindicated in patients with known hypersensitivity to lumateperone or any components of CAPLYTA. Reactions have included pruritus, rash (e.g. allergic dermatitis, papular rash, and generalized rash), and urticaria.

    Warnings & Precautions: Antipsychotic drugs have been reported to cause:

    • Cerebrovascular Adverse Reactions in Elderly Patients with Dementia-Related Psychosis, including stroke and transient ischemic attack. See Boxed Warning above.
    • Neuroleptic Malignant Syndrome (NMS), which is a potentially fatal reaction. Signs and symptoms include: high fever, stiff muscles, confusion, changes in breathing, heart rate, and blood pressure, elevated creatinine phosphokinase, myoglobinuria (and/or rhabdomyolysis), and acute renal failure. Patients who experience signs and symptoms of NMS should immediately contact their doctor or go to the emergency room.
    • Tardive Dyskinesia, a syndrome of uncontrolled body movements in the face, tongue, or other body parts, which may increase with duration of treatment and total cumulative dose. TD may not go away, even if CAPLYTA is discontinued. It can also occur after CAPLYTA is discontinued.
    • Metabolic Changes, including hyperglycemia, diabetes mellitus, dyslipidemia, and weight gain. Hyperglycemia, in some cases extreme and associated with ketoacidosis, hyperosmolar coma or death, has been reported in patients treated with antipsychotics. Measure weight and assess fasting plasma glucose and lipids when initiating CAPLYTA and monitor periodically during long-term treatment.
    • Leukopenia, Neutropenia, and Agranulocytosis (including fatal cases). Complete blood counts should be performed in patients with pre-existing low white blood cell count (WBC) or history of leukopenia or neutropenia. CAPLYTA should be discontinued if clinically significant decline in WBC occurs in absence of other causative factors.
    • Decreased Blood Pressure & Dizziness. Patients may feel lightheaded, dizzy or faint when they rise too quickly from a sitting or lying position (orthostatic hypotension). Heart rate and blood pressure should be monitored and patients should be warned with known cardiovascular or cerebrovascular disease. Orthostatic vital signs should be monitored in patients who are vulnerable to hypotension.
    • Falls. CAPLYTA may cause sleepiness or dizziness and can slow thinking and motor skills, which may lead to falls and, consequently, fractures and other injuries. Patients should be assessed for risk when using CAPLYTA.
    • Seizures. CAPLYTA should be used cautiously in patients with a history of seizures or with conditions that lower seizure threshold.
    • Sleepiness and Trouble Concentrating. Patients should use caution when operating machinery or motor vehicles until they know how CAPLYTA affects them.
    • Body Temperature Dysregulation. CAPLYTA should be used with caution in patients who may experience conditions that may increase core body temperature such as strenuous exercise, extreme heat, dehydration, or concomitant anticholinergics.
    • Dysphagia. CAPLYTA should be used with caution in patients at risk for aspiration.

    Drug Interactions: CAPLYTA should not be used with CYP3A4 inducers, moderate or strong CYP3A4 inhibitors and UGT inhibitors.

    Special Populations: Newborn infants exposed to antipsychotic drugs during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery. Breastfeeding is not recommended. Use of CAPLYTA should be avoided in patients with moderate or severe liver problems.

    Adverse Reactions: The most common adverse reactions in clinical trials with CAPLYTA vs. placebo were somnolence/sedation (24% vs. 10%) and dry mouth (6% vs. 2%).

    Please click here to see full Prescribing Information including Boxed Warning.

    About CAPLYTA (lumateperone)

    CAPLYTA 42mg/day is an oral, once daily atypical antipsychotic approved for the treatment of schizophrenia of adults. While the mechanism of action of CAPLYTA in the treatment of schizophrenia is unknown, the efficacy of CAPLYTA could be mediated through a combination of antagonist activity at central serotonin 5-HT2A receptors and postsynaptic antagonist activity at central dopamine D2 receptors.

    CAPLYTA (lumateperone) is being investigated for the treatment of bipolar depression, depression and other neuropsychiatric and neurological disorders. CAPLYTA is not FDA approved for these disorders.

    About Intra-Cellular Therapies

    Intra-Cellular Therapies is a biopharmaceutical company founded on Nobel prize-winning research that allows us to understand how therapies affect the inner-workings of cells in the body. The company leverages this intracellular approach to develop innovative treatments for people living with complex psychiatric and neurologic diseases. For more information, please visit www.intracellulartherapies.com.

    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 expectations regarding the commercialization of CAPLYTA; the anticipated timing of the FDA target action date for our bipolar depression sNDAs, if accepted by the FDA, and the adequacy of the data contained in the sNDAs to serve as the basis for approval of lumateperone for the treatment of depressive episodes associated with bipolar I or II disorder both as monotherapy and as adjunctive therapy in adults; our plans and expected timing to initiate our lumateperone clinical studies in major depressive disorder; our plans and expected timing for results from our lumateperone long-acting injectable clinical trial; our plans and expected timing for results from our from our ITI-333 clinical trial; our development plans for our PDE program, including ITI-214; our development plans for our ITI-1284 program; our beliefs about the potential utility of our product candidates; 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: whether the sNDAs for lumateperone will be accepted for review by the FDA; if accepted, whether the preclinical and clinical results of the lumateperone studies will meet the regulatory requirements for approval by the FDA for the proposed indications; whether the sNDAs will be approved by the FDA and whether the FDA will complete its review within its target timelines, including its target action date once established; whether the FDA will require additional information, whether we will be able to provide in a timely manner any additional information that the FDA requests, and whether such additional information will be satisfactory to the FDA; there are no guarantees that CAPLYTA will be commercially successful; we may encounter issues, delays or other challenges in commercializing CAPLYTA; the COVID-19 pandemic may negatively impact our commercial plans and sales for CAPLYTA; the COVID-19 pandemic may negatively impact the conduct of, and the timing of enrollment, completion and reporting with respect to, our clinical trials; whether CAPLYTA receives adequate reimbursement from third-party payors; the degree to which CAPLYTA receives acceptance from patients and physicians for its approved indication; challenges associated with execution of our sales activities, which in each case could limit the potential of our product; results achieved in CAPLYTA in the treatment of schizophrenia following commercial launch of the product may be different than observed in clinical trials, and may vary among patients; any other impacts on our business as a result of or related to the COVID-19 pandemic; risks associated with our current and planned clinical trials; we may encounter unexpected safety or tolerability issues with CAPLYTA following commercial launch for the treatment of schizophrenia or in ongoing or future trials and other development activities; 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 or in clinical trials for other indications; 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

     

    212-213-0006

    MEDIA INQUIRIES:

    Ana Fullmer

    Corporate Media Relations W2Owcg

     

    202-507-0130

    INTRA-CELLULAR THERAPIES, INC.

    CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

          
     Three Months Ended December 31,Year Ended December 31,
      2020

      2019

      2020(1)

      2019(1)

     
         
     (Unaudited)(Unaudited)(Unaudited)(Unaudited)
    Revenues    
    Product sales, net$12,403,754 $ $22,530,753 $ 
    Grant revenue 50,516  60,613  282,226  60,613 
    Revenues, net 12,454,270  60,613  22,812,979  60,613 
         
    Costs and expenses:    
    Cost of product sales 1,141,072    1,895,029   
    Research and development 14,298,586  19,065,725  65,782,137  89,124,838 
    Selling, general and administrative 58,347,948  22,763,547  186,363,444  64,947,625 
    Total costs and expenses 73,787,606  41,829,272  254,040,610  154,072,463 
         
    Loss from operations (61,333,336) (41,768,659) (231,227,631) (154,011,850)
    Interest income (644,390) (1,185,808) (4,235,481) (6,291,272)
    Income tax expense 10,232    13,513  1,600 
    Net loss$(60,699,178)$(40,582,851)$(227,005,663)$(147,722,178)
         
    Net loss per common share:    
    Basic & Diluted$(0.76)$(0.74)$(3.23)$(2.68)
         
    Weighted average number of common shares:    
    Basic & Diluted 80,293,750  55,276,251  70,364,800  55,186,206 

    (1)   The condensed consolidated statements of operations for the years ended December 31, 2020 and 2019 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

       
       
       
      December 31,

    2020 (1) 
       December 31,

    2019 (1)
     
       
    Assets  
    Current assets:  
    Cash and cash equivalents        $60,045,933  $107,636,849 
    Investment securities, available-for-sale         597,402,126   116,373,335 
    Restricted cash         1,400,000    
    Accounts receivable, less allowance of $120,000 and $0 at December 31, 2020 and 2019, respectively         10,764,583    
    Inventory         7,056,385    
    Prepaid expenses and other current assets         14,235,455   6,313,785 
    Total current assets         690,904,482   230,323,969 
    Property and equipment, net         1,998,346   2,259,740 
    Right of use assets, net         24,324,762   18,252,074 
    Deferred tax asset, net         —     264,609 
    Other assets         86,084   86,084 
    Total assets        $717,313,674  $251,186,476 
    Liabilities and stockholders' equity  
    Current liabilities:  
    Accounts payable        $5,501,825  $7,425,024 
    Accrued and other current liabilities         10,902,117   16,138,909 
    Lease liabilities, short-term         5,541,802   3,187,435 
    Accrued employee benefits         14,907,479   9,472,651 
    Total current liabilities         36,853,223   36,224,019 
    Lease liabilities         23,600,347   19,955,186 
    Total liabilities         60,453,570   56,179,205 
    Stockholders' equity:  
    Common stock, $0.0001 par value: 100,000,000 shares authorized; 80,463,089 and 55,507,497 shares issued and outstanding at December 31, 2020 and 2019, respectively         8,046   5,551 
    Additional paid-in capital         1,593,475,506   904,971,772 
    Accumulated deficit         (937,104,032)  (710,098,369)
    Accumulated comprehensive income         480,584   128,317 
    Total stockholders' equity         656,860,104   195,007,271 
    Total liabilities and stockholders' equity        $717,313,674  $251,186,476 
             

    (1)   The condensed consolidated balance sheets at December 31, 2020 and 2019 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.



     



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  2. ITI-1284 is a deuterated form of lumateperone delivered sublingually as an orally disintegrating tablet (ODT-SL). ITI-1284 ODT-SL may offer pharmacologic benefits and ease-of-use for patients, particularly in elderly populations.

    Phase 1 single ascending dose and multiple ascending dose studies have been completed in healthy volunteers including elderly subjects > than 65 years of age.

    Company plans to develop ITI-1284 for the treatment of behavioral disturbances in dementia, dementia-related psychosis, and certain depressive disorders in the elderly.

    NEW YORK, Feb. 24, 2021 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (NASDAQ:ITCI), a biopharmaceutical company focused on the development and commercialization of therapeutics for…

    ITI-1284 is a deuterated form of lumateperone delivered sublingually as an orally disintegrating tablet (ODT-SL). ITI-1284 ODT-SL may offer pharmacologic benefits and ease-of-use for patients, particularly in elderly populations.

    Phase 1 single ascending dose and multiple ascending dose studies have been completed in healthy volunteers including elderly subjects > than 65 years of age.

    Company plans to develop ITI-1284 for the treatment of behavioral disturbances in dementia, dementia-related psychosis, and certain depressive disorders in the elderly.

    NEW YORK, Feb. 24, 2021 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (NASDAQ:ITCI), a biopharmaceutical company focused on the development and commercialization of therapeutics for central nervous system (CNS) disorders, today announced the expansion of its pipeline with ITI-1284 ODT-SL. ITI-1284 is a deuterated form of lumateperone, a new molecular entity formulated as an oral disintegrating tablet for sublingual administration. Following recent completion of its Phase 1 program, the Company plans to develop ITI-1284 ODT-SL for the treatment of behavioral disturbances in patients with dementia, the treatment of dementia-related psychosis and the treatment of certain depressive disorders in the elderly.

    ITI-1284 ODT-SL is formulated as an oral solid dosage form that dissolves almost instantly when placed under the tongue, allowing for ease of use in the elderly and may be particularly beneficial for patients who have difficulty swallowing conventional tablets. ITI-1284 ODT-SL has been developed in collaboration with Catalent using its proprietary Zydis® ODT (orally disintegrating tablet) fast-dissolving formulation.

    Our recently completed Phase I program found that ITI-1284 ODT-SL was rapidly absorbed into the systemic circulation, was metabolically stable, and resulted in high systemic exposure. Our Phase 1 single and multiple ascending dose studies in healthy volunteers and healthy elderly volunteers (> than 65 years of age) evaluated the safety, tolerability and pharmacokinetics of ITI-1284. In these studies, there were no reported serious adverse events in either age group. In the elderly cohort, reported adverse events were infrequent with the most common adverse event being transient dry mouth (mild).

    Based on these studies, the Company plans to initiate Phase 2 studies evaluating ITI-1284 ODT-SL for the treatment of behavioral disturbances in dementia, dementia-related psychosis, and certain depressive disorders in the elderly.

    About ITI-1284

    ITI-1284 is a deuterated form of lumateperone where carbon-deuterium bonds strategically replace carbon-hydrogen bonds. ITI-1284 has high affinity for serotonin 5-HT2A receptors and moderate affinity for dopamine D2 and D1 receptors, and the serotonin transporter.

    ITI- 1284 is an investigational agent and has not been approved for use for any indication.

    About Intra-Cellular Therapies

    Intra-Cellular Therapies is a biopharmaceutical company founded on Nobel prize-winning research that allows us to understand how therapies affect the inner-workings of cells in the body. The company leverages this intracellular approach to develop innovative treatments for people living with complex psychiatric and neurologic diseases. For more information, please visit www.intracellulartherapies.com.

    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, the therapeutic value, clinical and non-clinical development plans and commercial potential of our drug product candidates; the progress, timing and results of our clinical trials and preclinical studies; our beliefs about the extent to which the results of our clinical trials and preclinical studies to date support new drug application filings for product candidates; the safety and efficacy of our product development candidates; our beliefs about the potential uses and benefits of our drug product candidates; 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 or other studies for our 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; the COVID-19 pandemic may negatively impact the conduct of, and the timing of enrollment, completion and reporting with respect to, our clinical trials; any other impacts on our business as a result of or related to the COVID-19 pandemic; 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



    212-213-0006

    MEDIA INQUIRIES:

    Ana Fullmer

    Corporate Media Relations W2Owcg



    202-507-0130



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    • ITCI submits Supplemental New Drug Applications (sNDAs) for the treatment of depressive episodes associated with bipolar I or II disorder both as monotherapy and as adjunctive therapy in adults.
    • If approved, CAPLYTA has the potential to treat the broadest range of patients with bipolar depression.

    NEW YORK, Feb. 22, 2021 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (NASDAQ:ITCI), a biopharmaceutical company focused on the development and commercialization of therapeutics for central nervous system (CNS) disorders, announced that it has recently submitted supplemental New Drug Applications (sNDAs) to the U.S. Food and Drug Administration (FDA) for two indications for CAPLYTA (lumateperone): 1) as monotherapy; and 2) as adjunctive therapy…

    • ITCI submits Supplemental New Drug Applications (sNDAs) for the treatment of depressive episodes associated with bipolar I or II disorder both as monotherapy and as adjunctive therapy in adults.
    • If approved, CAPLYTA has the potential to treat the broadest range of patients with bipolar depression.

    NEW YORK, Feb. 22, 2021 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (NASDAQ:ITCI), a biopharmaceutical company focused on the development and commercialization of therapeutics for central nervous system (CNS) disorders, announced that it has recently submitted supplemental New Drug Applications (sNDAs) to the U.S. Food and Drug Administration (FDA) for two indications for CAPLYTA (lumateperone): 1) as monotherapy; and 2) as adjunctive therapy with lithium or valproate for the treatment of depressive episodes associated with bipolar I or II disorder (bipolar depression) in adults. If approved, CAPLYTA would be the first therapy indicated for the treatment of depressive episodes associated with bipolar I or II disorder both as monotherapy and as adjunctive therapy in adults. The Company anticipates an FDA target action date for the sNDAs in the second half of 2021.

    Two positive Phase 3 global placebo-controlled bipolar depression studies, Study 402 and Study 404, form the basis of the sNDAs. In these trials, lumateperone 42 mg demonstrated a favorable tolerability and safety profile, consistent with findings in all of the Company's previous studies in schizophrenia. The most commonly reported adverse events (defined as a rate greater than or equal to 5% and at least twice the rate of placebo) were somnolence, dizziness and nausea. Importantly, the rates of akathisia, restlessness and extrapyramidal symptoms were low and similar to placebo.  

    Results from Study 404 have been presented at scientific conferences. Results from Study 402 will be presented at the American Psychiatric Association annual meeting in May of this year.

    "Bipolar I and II disorders are severe mental health conditions that affect approximately 11 million adults in the U.S. and there remains a significant need for more treatment options," said Dr. Sharon Mates, Chairman and CEO of Intra-Cellular Therapies. "We believe CAPLYTA has the potential to be an important option for patients in the treatment of bipolar depression. We look forward to bringing CAPLYTA to market, if approved, for the treatment of bipolar depression."

    About Bipolar Depression

    Bipolar I and Bipolar II disorder are serious, highly prevalent psychiatric conditions affecting approximately 11 million adults in the U.S.

    These disorders are characterized by recurrent episodes of mania or hypomania interspersed with episodes of major depression known as Bipolar depression. Bipolar I and Bipolar II each represent about half of the overall population of patients with bipolar disorder.

    Bipolar depression is the most common clinical presentation of bipolar disorder. These episodes tend to last longer, recur more often, and are associated with a worse prognosis than the manic/hypomanic episodes. Bipolar depression remains a significantly underserved medical need, with only a few FDA-approved treatment options available. These treatments are commonly associated with tolerability issues.

    CAPLYTA® (lumateperone) is under investigation for the treatment of bipolar disorder. The safety and efficacy for this use has not been established.

    CAPLYTA is indicated for the treatment of schizophrenia in adults. CAPLYTA is available in 42 mg capsules.

    Important Safety Information

    Boxed Warning: Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. CAPLYTA is not approved for the treatment of patients with dementia-related psychosis.

    Contraindications: CAPLYTA is contraindicated in patients with known hypersensitivity to lumateperone or any components of CAPLYTA. Reactions have included pruritus, rash (e.g. allergic dermatitis, papular rash, and generalized rash), and urticaria.

    Warnings & Precautions: Antipsychotic drugs have been reported to cause:

    • Cerebrovascular Adverse Reactions in Elderly Patients with Dementia-Related Psychosis, including stroke and transient ischemic attack. See Boxed Warning above.
    • Neuroleptic Malignant Syndrome (NMS), which is a potentially fatal reaction. Signs and symptoms include: high fever, stiff muscles, confusion, changes in breathing, heart rate, and blood pressure, elevated creatinine phosphokinase, myoglobinuria (and/or rhabdomyolysis), and acute renal failure. Patients who experience signs and symptoms of NMS should immediately contact their doctor or go to the emergency room.
    • Tardive Dyskinesia, a syndrome of uncontrolled body movements in the face, tongue, or other body parts, which may increase with duration of treatment and total cumulative dose. TD may not go away, even if CAPLYTA is discontinued. It can also occur after CAPLYTA is discontinued.
    • Metabolic Changes, including hyperglycemia, diabetes mellitus, dyslipidemia, and weight gain. Hyperglycemia, in some cases extreme and associated with ketoacidosis, hyperosmolar coma or death, has been reported in patients treated with antipsychotics. Measure weight and assess fasting plasma glucose and lipids when initiating CAPLYTA and monitor periodically during long-term treatment.
    • Leukopenia, Neutropenia, and Agranulocytosis (including fatal cases). Complete blood counts should be performed in patients with pre-existing low white blood cell count (WBC) or history of leukopenia or neutropenia. CAPLYTA should be discontinued if clinically significant decline in WBC occurs in absence of other causative factors.
    • Decreased Blood Pressure & Dizziness. Patients may feel lightheaded, dizzy or faint when they rise too quickly from a sitting or lying position (orthostatic hypotension). Heart rate and blood pressure should be monitored and patients should be warned with known cardiovascular or cerebrovascular disease. Orthostatic vital signs should be monitored in patients who are vulnerable to hypotension.
    • Falls. CAPLYTA may cause sleepiness or dizziness and can slow thinking and motor skills, which may lead to falls and, consequently, fractures and other injuries. Patients should be assessed for risk when using CAPLYTA.
    • Seizures. CAPLYTA should be used cautiously in patients with a history of seizures or with conditions that lower seizure threshold.
    • Sleepiness and Trouble Concentrating. Patients should use caution when operating machinery or motor vehicles until they know how CAPLYTA affects them.
    • Body Temperature Dysregulation. CAPLYTA should be used with caution in patients who may experience conditions that may increase core body temperature such as strenuous exercise, extreme heat, dehydration, or concomitant anticholinergics.
    • Dysphagia. CAPLYTA should be used with caution in patients at risk for aspiration.

    Drug Interactions: CAPLYTA should not be used with CYP3A4 inducers, moderate or strong CYP3A4 inhibitors and UGT inhibitors.

    Special Populations: Newborn infants exposed to antipsychotic drugs during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery. Breastfeeding is not recommended. Use of CAPLYTA should be avoided in patients with moderate or severe liver problems.

    Adverse Reactions: The most common adverse reactions in clinical trials with CAPLYTA vs. placebo were somnolence/sedation (24% vs. 10%) and dry mouth (6% vs. 2%).

    Please click here to see full Prescribing Information including Boxed Warning.

    About CAPLYTA (lumateperone)

    CAPLYTA 42mg/day is an oral, once daily atypical antipsychotic approved for the treatment of schizophrenia of adults. While the mechanism of action of CAPLYTA in the treatment of schizophrenia is unknown, the efficacy of CAPLYTA could be mediated through a combination of antagonist activity at central serotonin 5-HT2A receptors and postsynaptic antagonist activity at central dopamine D2 receptors.

    Lumateperone is being investigated for the treatment of bipolar depression, depression and other neuropsychiatric and neurological disorders. Lumateperone is not FDA approved for these disorders.

    About Intra-Cellular Therapies

    Intra-Cellular Therapies is a biopharmaceutical company founded on Nobel prize-winning research that allows us to understand how therapies affect the inner-workings of cells in the body. The company leverages this intracellular approach to develop innovative treatments for people living with complex psychiatric and neurologic diseases. For more information, please visit www.intracellulartherapies.com.

    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, expectations regarding the sNDAs, including expectations about the timing of the FDA target action date and the adequacy of the data contained in the sNDAs to serve as the basis for approval of lumateperone for the treatment of depressive episodes associated with bipolar I or II disorder both as monotherapy and as adjunctive therapy in adults; our beliefs about the potential utility of our product candidates; 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: whether the sNDAs for lumateperone will be accepted for review by the FDA; if accepted, whether the preclinical and clinical results of the lumateperone studies will meet the regulatory requirements for approval by the FDA for the proposed indications; whether the sNDAs will be approved by the FDA and whether the FDA will complete its review within its target timelines, including its target action date once established; whether the FDA will require additional information, whether we will be able to provide in a timely manner any additional information that the FDA requests, and whether such additional information will be satisfactory to the FDA; there are no guarantees that CAPLYTA will be commercially successful; we may encounter issues, delays or other challenges in commercializing CAPLYTA; the COVID-19 pandemic may negatively impact our commercial plans and sales for CAPLYTA; the COVID-19 pandemic may negatively impact the conduct of, and the timing of enrollment, completion and reporting with respect to, our clinical trials; whether CAPLYTA receives adequate reimbursement from third-party payors; the degree to which CAPLYTA receives acceptance from patients and physicians for its approved indication; challenges associated with execution of our sales activities, which in each case could limit the potential of our product; results achieved in CAPLYTA in the treatment of schizophrenia following commercial launch of the product may be different than observed in clinical trials, and may vary among patients; any other impacts on our business as a result of or related to the COVID-19 pandemic; risks associated with our current and planned clinical trials; we may encounter unexpected safety or tolerability issues with CAPLYTA following commercial launch for the treatment of schizophrenia or in ongoing or future trials and other development activities; 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 or in clinical trials for other indications; 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



    212-213-0006

    MEDIA INQUIRIES:

    Ana Fullmer

    Corporate Media Relations W2Owcg



    202-507-0130



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  3. NEW YORK, Feb. 19, 2021 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (NASDAQ:ITCI), a biopharmaceutical company focused on the development and commercialization of therapeutics for central nervous system (CNS) disorders, today announced that Sharon Mates, Ph.D., Chief Executive Officer and Chairman, is scheduled to present at the SVB Leerink 10th Annual Global Healthcare Conference on Friday, February 26, 2021 at 10:00 am ET.

    The live and archived webcast can be accessed under "Events & Presentations" in the Investor Relations section of the Company's website at www.intracellulartherapies.com. Please log in approximately 5-10 minutes prior to the event to register and to download and install any necessary software.

    About Intra-Cellular

    NEW YORK, Feb. 19, 2021 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (NASDAQ:ITCI), a biopharmaceutical company focused on the development and commercialization of therapeutics for central nervous system (CNS) disorders, today announced that Sharon Mates, Ph.D., Chief Executive Officer and Chairman, is scheduled to present at the SVB Leerink 10th Annual Global Healthcare Conference on Friday, February 26, 2021 at 10:00 am ET.

    The live and archived webcast can be accessed under "Events & Presentations" in the Investor Relations section of the Company's website at www.intracellulartherapies.com. Please log in approximately 5-10 minutes prior to the event to register and to download and install any necessary software.

    About Intra-Cellular Therapies

    Intra-Cellular Therapies is a biopharmaceutical company founded on Nobel prize-winning research that allows us to understand how therapies affect the inner-workings of cells in the body. The company leverages this intracellular approach to develop innovative treatments for people living with complex psychiatric and neurologic diseases.

    CONTACT:

    Intra-Cellular Therapies, Inc.

    Juan Sanchez, M.D.

    Vice President, Corporate Communications and Investor Relations

    646-440-9333

    Burns McClellan, Inc.

    Lisa Burns

    John Grimaldi



    212-213-0006



    Primary Logo

    View Full Article Hide Full Article
  4. NEW YORK, Feb. 17, 2021 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (NASDAQ:ITCI), a biopharmaceutical company focused on the development and commercialization of therapeutics for central nervous system (CNS) disorders, today announced that it will host a conference call and live webcast discussion at 8:30 a.m. Eastern Time on Thursday, February 25, 2021, to provide a corporate update and discuss details of the Company's financial results for the quarter and year ended December 31, 2020.

    To access the live conference call via phone, dial 1-(844) 835-6563. The international dial-in number is 1-(970) 315-3916. The conference ID number for the live call is 8499868.

    The live and archived webcast can be accessed under "Events & Presentations…

    NEW YORK, Feb. 17, 2021 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (NASDAQ:ITCI), a biopharmaceutical company focused on the development and commercialization of therapeutics for central nervous system (CNS) disorders, today announced that it will host a conference call and live webcast discussion at 8:30 a.m. Eastern Time on Thursday, February 25, 2021, to provide a corporate update and discuss details of the Company's financial results for the quarter and year ended December 31, 2020.

    To access the live conference call via phone, dial 1-(844) 835-6563. The international dial-in number is 1-(970) 315-3916. The conference ID number for the live call is 8499868.

    The live and archived webcast can be accessed under "Events & Presentations" in the Investor Relations section of the Company's website at www.intracellulartherapies.com. Please log in approximately 5-10 minutes prior to the event to register and to download and install any necessary software.

    About Intra-Cellular Therapies

    Intra-Cellular Therapies is a biopharmaceutical company founded on Nobel prize-winning research that allows us to understand how therapies affect the inner-workings of cells in the body. The company leverages this intracellular approach to develop innovative treatments for people living with complex psychiatric and neurologic diseases. For more information, please visit www.intracellulartherapies.com.

    Contact

    Intra-Cellular Therapies, Inc.

    Juan Sanchez, M.D.

    Vice President, Corporate Communications and Investor Relations

    646-440-9333

    Burns McClellan, Inc.

    Lisa Burns



    212-213-0006

    Source: Intra-Cellular Therapies Inc.

     



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  5. Patients with stable symptoms of schizophrenia were switched from previous antipsychotic medications with no dose titration to CAPLYTA 42 mg for a 6-week treatment duration, then switched back to previous or another approved antipsychotic.

    In patients with stable symptoms of schizophrenia, CAPLYTA was well-tolerated with low rates of metabolic and extrapyramidal symptoms (EPS) adverse events; schizophrenia symptoms remained stable and did not worsen from baseline.

    NEW YORK, Jan. 21, 2021 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (NASDAQ:ITCI), a biopharmaceutical company focused on the development and commercialization of therapeutics for central nervous system (CNS) disorders, today announced the publication of results from the…

    Patients with stable symptoms of schizophrenia were switched from previous antipsychotic medications with no dose titration to CAPLYTA 42 mg for a 6-week treatment duration, then switched back to previous or another approved antipsychotic.

    In patients with stable symptoms of schizophrenia, CAPLYTA was well-tolerated with low rates of metabolic and extrapyramidal symptoms (EPS) adverse events; schizophrenia symptoms remained stable and did not worsen from baseline.

    NEW YORK, Jan. 21, 2021 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (NASDAQ:ITCI), a biopharmaceutical company focused on the development and commercialization of therapeutics for central nervous system (CNS) disorders, today announced the publication of results from the CAPLYTA clinical trial (ITI-007-303) in adult patients with schizophrenia. The article, "Safety and tolerability of lumateperone 42 mg: An open-label antipsychotic switch study in outpatients with stable schizophrenia" (Correll et al. 2021), was recently published online in Schizophrenia Research and is available here.

    The objective of this 6-week open-label study was to evaluate the safety and tolerability of CAPLYTA with stable schizophrenia patients switched from another antipsychotic treatment. The most common drug-related treatment emergent adverse events during CAPLYTA treatment were somnolence (6.6%), headache (5.3%) and dry mouth (5.3%). Reports of EPS were low (1%).

    After 6 weeks of CAPLYTA treatment, it was observed that the mean total cholesterol, low-density lipoprotein (LDL) cholesterol, body weight and prolactin levels decreased from baseline. At the conclusion of the treatment period with CAPLYTA, patients were switched back to their previous or another approved antipsychotic. In a prespecified secondary safety analysis, conducted 2 weeks after discontinuing CAPLYTA, it was observed that the mean total cholesterol, LDL cholesterol, body weight and prolactin levels increased. In this study, patients' schizophrenia symptoms remained stable and did not worsen from baseline.

    These data further support the safety, tolerability and effectiveness of CAPLYTA in patients with schizophrenia and provide important information to clinicians.

    "Weight gain and metabolic side effects or motor disturbances are leading reasons for healthcare providers to switch antipsychotics. Scientific results from studies that resemble a real world clinical setting and published in the medical literature provide important information for clinicians to make informed treatment decisions," said Dr. Christoph Correll, Professor of Psychiatry and Molecular Medicine at the Zucker School of Medicine at Hofstra/Northwell, New York. "CAPLYTA is a valuable addition to the armamentarium to help treat this challenging mental illness."

    About ITI-007-303

    ITI-007-303 is an open label, multicenter study conducted in the United States to investigate the safety and effectiveness of up to 1 year of treatment with CAPLYTA 42 mg in 301 stable patients with schizophrenia after switching from previous antipsychotic medications with no dose titration to CAPLYTA 42 mg. The study was conducted in 2 parts.

    In Part 1, patients were eligible for participation if they had stable psychopathology and were able to be treated on an outpatient basis after Day 5. Entering the screening period on an existing antipsychotic was not a requirement of the study; therefore, medication history could not always be verified.

    Patients meeting entry criteria were required to discontinue previous antipsychotics, tapering as appropriate, prior to starting CAPLYTA 42 mg with no dose titration. The primary objective assessed adverse events (AE), vital signs, laboratory tests, and extrapyramidal symptoms (EPS). Three hundred and one patients received CAPLYTA in the study and the 6-week treatment was completed by 218 (72.2%) of patients. The most common reason for treatment discontinuation was adverse events (8.9%). At the conclusion of the treatment period with CAPLYTA, patients were switched to their previous or another approved antipsychotic and a follow-up safety assessment was conducted approximately 2 weeks later. 

    In Part 2 of this study, patients were treated for up to 1 year and the favorable safety profile was maintained. Data from Part 2 of the study will be published in a separate report.

    CAPLYTA® (lumateperone) is indicated for the treatment of schizophrenia in adults. CAPLYTA is available in 42 mg capsules.

    Important Safety Information

    Boxed Warning: Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. CAPLYTA is not approved for the treatment of patients with dementia-related psychosis.

    Contraindications: CAPLYTA is contraindicated in patients with known hypersensitivity to lumateperone or any components of CAPLYTA. Reactions have included pruritus, rash (e.g. allergic dermatitis, papular rash, and generalized rash), and urticaria.

    Warnings & Precautions: Antipsychotic drugs have been reported to cause:

    • Cerebrovascular Adverse Reactions in Elderly Patients with Dementia-Related Psychosis, including stroke and transient ischemic attack. See Boxed Warning above.
    • Neuroleptic Malignant Syndrome (NMS), which is a potentially fatal reaction. Signs and symptoms include: high fever, stiff muscles, confusion, changes in breathing, heart rate, and blood pressure, elevated creatinine phosphokinase, myoglobinuria (and/or rhabdomyolysis), and acute renal failure. Patients who experience signs and symptoms of NMS should immediately contact their doctor or go to the emergency room.
    • Tardive Dyskinesia, a syndrome of uncontrolled body movements in the face, tongue, or other body parts, which may increase with duration of treatment and total cumulative dose. TD may not go away, even if CAPLYTA is discontinued. It can also occur after CAPLYTA is discontinued.
    • Metabolic Changes, including hyperglycemia, diabetes mellitus, dyslipidemia, and weight gain. Hyperglycemia, in some cases extreme and associated with ketoacidosis, hyperosmolar coma or death, has been reported in patients treated with antipsychotics. Measure weight and assess fasting plasma glucose and lipids when initiating CAPLYTA and monitor periodically during long-term treatment.
    • Leukopenia, Neutropenia, and Agranulocytosis (including fatal cases). Complete blood counts should be performed in patients with pre-existing low white blood cell count (WBC) or history of leukopenia or neutropenia. CAPLYTA should be discontinued if clinically significant decline in WBC occurs in absence of other causative factors.
    • Decreased Blood Pressure & Dizziness. Patients may feel lightheaded, dizzy or faint when they rise too quickly from a sitting or lying position (orthostatic hypotension). Heart rate and blood pressure should be monitored and patients should be warned with known cardiovascular or cerebrovascular disease. Orthostatic vital signs should be monitored in patients who are vulnerable to hypotension.
    • Falls. CAPLYTA may cause sleepiness or dizziness and can slow thinking and motor skills, which may lead to falls and, consequently, fractures and other injuries. Patients should be assessed for risk when using CAPLYTA.
    • Seizures. CAPLYTA should be used cautiously in patients with a history of seizures or with conditions that lower seizure threshold.
    • Sleepiness and Trouble Concentrating. Patients should use caution when operating machinery or motor vehicles until they know how CAPLYTA affects them.
    • Body Temperature Dysregulation. CAPLYTA should be used with caution in patients who may experience conditions that may increase core body temperature such as strenuous exercise, extreme heat, dehydration, or concomitant anticholinergics.
    • Dysphagia. CAPLYTA should be used with caution in patients at risk for aspiration.

    Drug Interactions: CAPLYTA should not be used with CYP3A4 inducers, moderate or strong CYP3A4 inhibitors and UGT inhibitors.

    Special Populations: Newborn infants exposed to antipsychotic drugs during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery. Breastfeeding is not recommended. Use of CAPLYTA should be avoided in patients with moderate or severe liver problems.

    Adverse Reactions: The most common adverse reactions in clinical trials with CAPLYTA vs. placebo were somnolence/sedation (24% vs. 10%) and dry mouth (6% vs. 2%).

    Please click here to see full Prescribing Information including Boxed Warning.

    About CAPLYTA (lumateperone)

    CAPLYTA 42mg/day is an oral, once daily atypical antipsychotic approved for the treatment of schizophrenia of adults. While the mechanism of action of CAPLYTA in the treatment of schizophrenia is unknown, the efficacy of CAPLYTA could be mediated through a combination of antagonist activity at central serotonin 5-HT2A receptors and postsynaptic antagonist activity at central dopamine D2 receptors.

    About Intra-Cellular Therapies

    Intra-Cellular Therapies is a biopharmaceutical company founded on Nobel prize-winning research that allows us to understand how therapies affect the inner-workings of cells in the body. The company leverages this intracellular approach to develop innovative treatments for people living with complex psychiatric and neurologic diseases. For more information, please visit www.intracellulartherapies.com.

    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, whether clinical trial results will be predictive of future real-world results; our beliefs about the potential utility of our product candidates; 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: there are no guarantees that CAPLYTA will be commercially successful; we may encounter issues, delays or other challenges in commercializing CAPLYTA; the COVID-19 pandemic may negatively impact our commercial plans and sales for CAPLYTA; the COVID-19 pandemic may negatively impact the conduct of, and the timing of enrollment, completion and reporting with respect to, our clinical trials; whether CAPLYTA receives adequate reimbursement from third-party payors; the degree to which CAPLYTA receives acceptance from patients and physicians for its approved indication; challenges associated with execution of our sales activities, which in each case could limit the potential of our product; results achieved in CAPLYTA in the treatment of schizophrenia following commercial launch of the product may be different than observed in clinical trials, and may vary among patients; any other impacts on our business as a result of or related to the COVID-19 pandemic; risks associated with our current and planned clinical trials; we may encounter unexpected safety or tolerability issues with CAPLYTA following commercial launch for the treatment of schizophrenia or in ongoing or future trials and other development activities; 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 or in clinical trials for other indications; 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



    212-213-0006

    MEDIA INQUIRIES:

    Ana Fullmer

    Corporate Media Relations W2Owcg



    202-507-0130



    Primary Logo

    View Full Article Hide Full Article
  6. NEW YORK, Jan. 05, 2021 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (NASDAQ:ITCI), a biopharmaceutical company focused on the development and commercialization of therapeutics for central nervous system (CNS) disorders, today announced that Sharon Mates, Ph.D., Chief Executive Officer and Chairman, is scheduled to present at the 39th Annual J.P. Morgan Healthcare Conference on Tuesday, January 12, 2021 at 9:10 am ET.

    The live and archived webcast can be accessed under "Events & Presentations" in the Investor Relations section of the Company's website at www.intracellulartherapies.com. Please log in approximately 5-10 minutes prior to the event to register and to download and install any necessary software.

    About Intra-Cellular Therapies

    NEW YORK, Jan. 05, 2021 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (NASDAQ:ITCI), a biopharmaceutical company focused on the development and commercialization of therapeutics for central nervous system (CNS) disorders, today announced that Sharon Mates, Ph.D., Chief Executive Officer and Chairman, is scheduled to present at the 39th Annual J.P. Morgan Healthcare Conference on Tuesday, January 12, 2021 at 9:10 am ET.

    The live and archived webcast can be accessed under "Events & Presentations" in the Investor Relations section of the Company's website at www.intracellulartherapies.com. Please log in approximately 5-10 minutes prior to the event to register and to download and install any necessary software.

    About Intra-Cellular Therapies

    Intra-Cellular Therapies is a biopharmaceutical company founded on Nobel prize-winning research that allows us to understand how therapies affect the inner-workings of cells in the body. The company leverages this intracellular approach to develop innovative treatments for people living with complex psychiatric and neurologic diseases.

    CONTACT:

    Intra-Cellular Therapies, Inc.

    Juan Sanchez, M.D.

    Vice President, Corporate Communications and Investor Relations

    646-440-9333

    Burns McClellan, Inc.

    Lisa Burns

    John Grimaldi



    212-213-0006

    Source: Intra-Cellular Therapies Inc.



    Primary Logo

    View Full Article Hide Full Article
  7. The Company continues expansion of its lumateperone programs with the advancement of a Long-Acting injectable formulation into clinical trials.

    ITI-333 introduces a unique pharmacology for the treatment of opioid use disorder.

    NEW YORK, Dec. 29, 2020 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (NASDAQ:ITCI), a biopharmaceutical company focused on the development and commercialization of therapeutics for central nervous system (CNS) disorders, today announced the initiation of clinical programs for the Company's lumateperone long-acting injectable formulation (ITI-LLAI) and for ITI-333, a novel molecule for the treatment of opioid use disorder.

    "I am pleased to announce that two important proprietary programs have advanced into human…

    The Company continues expansion of its lumateperone programs with the advancement of a Long-Acting injectable formulation into clinical trials.

    ITI-333 introduces a unique pharmacology for the treatment of opioid use disorder.

    NEW YORK, Dec. 29, 2020 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (NASDAQ:ITCI), a biopharmaceutical company focused on the development and commercialization of therapeutics for central nervous system (CNS) disorders, today announced the initiation of clinical programs for the Company's lumateperone long-acting injectable formulation (ITI-LLAI) and for ITI-333, a novel molecule for the treatment of opioid use disorder.

    "I am pleased to announce that two important proprietary programs have advanced into human clinical testing, further demonstrating our commitment to patients through the development of novel treatments for schizophrenia, mood disorders and other neuropsychiatric and neurologic disorders," said Dr. Sharon Mates, Chairman and CEO of Intra-Cellular Therapies.

    LLAI, Study ITI-007-025: A Phase 1 single ascending dose study of LLAI, a formulation designed to be administered subcutaneously and to maintain therapeutic levels of lumateperone for at least 1 month. This study will evaluate the pharmacokinetics, safety and tolerability of lumateperone LAI in patients with stable symptoms of schizophrenia. Results from this study will inform the dosing strategy for future studies.

    Maintaining patients symptomatically stable and functional are the primary objectives of the treatment of schizophrenia. Long-acting injectable antipsychotics provide patients with blood concentrations of active drug that remain within a therapeutic range for an extended period. These formulations represent a treatment option for patients who prefer not to take medication daily or have history of poor adherence to oral treatments as they have the potential to improve adherence and prevent relapse. Oral lumateperone has demonstrated efficacy in treating schizophrenia symptoms with a favorable safety and tolerability profile. A long-acting formulation of lumateperone if successfully developed and approved will provide an additional option for patients.

    ITI-333, Study ITI-333-001: A Phase 1 single ascending dose study evaluating the safety, tolerability and pharmacokinetics of ITI-333 in healthy volunteers. ITI333 is a novel compound that uniquely combines activity as an antagonist at serotonin 5-HT2A receptors and a partial agonist at μ-opioid receptors. These combined actions support the potential utility of ITI-333 in the treatment of opioid use disorder and associated comorbidities (e.g., depression, anxiety, sleep disorders) without opioid-like safety and tolerability concerns.

    Opioid use disorder is a chronic disorder with over 10 million people in the United States having misused opioids and nearly fifty-thousand persons died from opioid drug overdoses in 2018.

    About Lumateperone Long Acting Injectable (LLAI) formulation

    The Company is developing a long-acting injectable formulation of lumateperone (LLAI) that is designed for once monthly administration by subcutaneous injection for the treatment of schizophrenia. Nonclinical studies in rodents and monkeys have shown the LLAI formulation is safe and well tolerated in single and once monthly multiple dose studies and sustains plasma lumateperone levels for 28 day or longer after each injection.

    Pharmacodynamic studies have shown lumateperone acts as a potent serotonin 5-HT2A receptor antagonist with high binding affinity, as a postsynaptic D2 receptor antagonist with moderate binding affinity, as an inhibitor of the serotonin reuptake transporter (SERT) with moderate binding affinity. Lumateperone also has moderate binding affinity to the D1 receptor (which may contribute to the indirect activation of NMDA and AMPA neurotransmission).  These drug targets are believed to play an important role in in schizophrenia, bipolar disorder, depressive disorders and other neuropsychiatric disorders.  In vitro studies have shown lumateperone has a ~60-fold greater affinity for 5-HT2A receptors vs D2 receptors.

    Lumateperone is being investigated for the treatment of bipolar depression, major depressive disorders and other neuropsychiatric and neurological disorders. Lumateperone is not FDA approved for these disorders. CAPLYTA 42 mg (lumateperone) is approved by the U.S. Food and Drug Administration for the treatment schizophrenia of adults.

    About ITI-333

    ITI333 is a novel compound that uniquely combines activity as an antagonist at serotonin 5-HT2A receptors and a partial agonist at μ-opioid receptors. These combined actions support the potential utility of ITI-333 in the treatment of opioid use disorder and associated comorbidities (e.g., depression, anxiety, sleep disorders) without opioid-like safety and tolerability concerns. In addition, ITI-333 exhibits analgesic efficacy in acute and chronic preclinical models of pain supporting its potential utility in the management of pain.

    ITI333's pharmacology is predominantly driven by high affinity binding to serotonin 5-HT2A (Ki = 8.3 nM) and μ-opioid (Ki = 11 nM) receptors. ITI333 shows modest affinity for dopamine D1 receptors, low affinity for κ-opioid receptors, and no binding to δ-opioid and NOP receptors.

    In vivo, ITI-333 elicits potent analgesia in rodents that is blocked by the opioid antagonist, naloxone. Further, ITI-333 mitigates symptoms associated with opioid withdrawal and blocks reinstatement of opioid mediated behaviors; behaviors thought to be associated with a return to opioid use after a period of abstinence.

    ITI-333 possesses low potential for abuse liability. Unlike opioid agonists, ITI-333 is not self-administered, does not develop physical tolerance/dependences and does not impair gastrointestinal and pulmonary function. This pharmacologic profile is unique and supports the study of ITI-333 in humans as a potential treatment for opioid use disorder and pain.

    Intra-Cellular Therapies has received a grant from the National Institute on Drug Abuse as part of the NIH Helping to End Addiction Long-term initiative, or HEAL, to support the early clinical development of ITI-333 for the treatment of opioid use disorder.

    CAPLYTA™ (lumateperone) is indicated for the treatment of schizophrenia in adults. CAPLYTA is available in 42 mg capsules.

    Important Safety Information

    Boxed Warning: Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. CAPLYTA is not approved for the treatment of patients with dementia-related psychosis.

    Contraindications: CAPLYTA is contraindicated in patients with known hypersensitivity to lumateperone or any components of CAPLYTA. Reactions have included pruritus, rash (e.g. allergic dermatitis, papular rash, and generalized rash), and urticaria.

    Warnings & Precautions: Antipsychotic drugs have been reported to cause:

    • Cerebrovascular Adverse Reactions in Elderly Patients with Dementia-Related Psychosis, including stroke and transient ischemic attack. See Boxed Warning above.
    • Neuroleptic Malignant Syndrome (NMS), which is a potentially fatal reaction. Signs and symptoms include: high fever, stiff muscles, confusion, changes in breathing, heart rate, and blood pressure, elevated creatinine phosphokinase, myoglobinuria (and/or rhabdomyolysis), and acute renal failure. Patients who experience signs and symptoms of NMS should immediately contact their doctor or go to the emergency room.
    • Tardive Dyskinesia, a syndrome of uncontrolled body movements in the face, tongue, or other body parts, which may increase with duration of treatment and total cumulative dose. TD may not go away, even if CAPLYTA is discontinued. It can also occur after CAPLYTA is discontinued.
    • Metabolic Changes, including hyperglycemia, diabetes mellitus, dyslipidemia, and weight gain. Hyperglycemia, in some cases extreme and associated with ketoacidosis, hyperosmolar coma or death, has been reported in patients treated with antipsychotics. Measure weight and assess fasting plasma glucose and lipids when initiating CAPLYTA and monitor periodically during long-term treatment.
    • Leukopenia, Neutropenia, and Agranulocytosis (including fatal cases). Complete blood counts should be performed in patients with pre-existing low white blood cell count (WBC) or history of leukopenia or neutropenia. CAPLYTA should be discontinued if clinically significant decline in WBC occurs in absence of other causative factors.
    • Decreased Blood Pressure & Dizziness. Patients may feel lightheaded, dizzy or faint when they rise too quickly from a sitting or lying position (orthostatic hypotension). Heart rate and blood pressure should be monitored and patients should be warned with known cardiovascular or cerebrovascular disease. Orthostatic vital signs should be monitored in patients who are vulnerable to hypotension.
    • Falls. CAPLYTA may cause sleepiness or dizziness and can slow thinking and motor skills, which may lead to falls and, consequently, fractures and other injuries. Patients should be assessed for risk when using CAPLYTA.
    • Seizures. CAPLYTA should be used cautiously in patients with a history of seizures or with conditions that lower seizure threshold.
    • Sleepiness and Trouble Concentrating. Patients should use caution when operating machinery or motor vehicles until they know how CAPLYTA affects them.
    • Body Temperature Dysregulation. CAPLYTA should be used with caution in patients who may experience conditions that may increase core body temperature such as strenuous exercise, extreme heat, dehydration, or concomitant anticholinergics.
    • Dysphagia. CAPLYTA should be used with caution in patients at risk for aspiration.

      Drug Interactions: CAPLYTA should not be used with CYP3A4 inducers, moderate or strong CYP3A4 inhibitors and UGT inhibitors.

      Special Populations: Newborn infants exposed to antipsychotic drugs during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery. Breastfeeding is not recommended. Use of CAPLYTA should be avoided in patients with moderate or severe liver problems.

      Adverse Reactions: The most common adverse reactions in clinical trials with CAPLYTA vs. placebo were somnolence/sedation (24% vs. 10%) and dry mouth (6% vs. 2%).

      Please click here to see full Prescribing Information including Boxed Warning.

    About Intra-Cellular Therapies

    Intra-Cellular Therapies is a biopharmaceutical company founded on Nobel prize-winning research that allows us to understand how therapies affect the inner-workings of cells in the body. The company leverages this intracellular approach to develop innovative treatments for people living with complex psychiatric and neurologic diseases.

    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 beliefs about the potential utility of our product candidates; our belief that a long-acting injectable formulation of lumateperone could represent an important treatment option for patients; our expectation that we will continue to invest in our drug development pipeline; 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: the COVID-19 pandemic may negatively impact the conduct of, and the timing of enrollment, completion and reporting with respect to, our clinical trials; any other impacts on our business as a result of or related to the COVID-19 pandemic; risks associated with our current and planned clinical trials; we may encounter unexpected safety or tolerability issues in ongoing or future trials and other development activities; 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 or in clinical trials for other indications; 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

    John Grimaldi



    212-213-0006 



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  8. Presentations highlight lumateperone's broad antidepressant effects in patients with bipolar disorder and in patients with schizophrenia with co-morbid depression

    NEW YORK, Dec. 09, 2020 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (NASDAQ:ITCI), a biopharmaceutical company focused on the development and commercialization of therapeutics for central nervous system (CNS) disorders, today announced two presentations at the 59th Annual Meeting of the American College of Neuropsychopharmacology (ACNP) being held virtually, December 6-9, 2020.

    • "Lumateperone (ITI-007) in the Treatment of Bipolar Depression: Efficacy Across Symptoms" (Poster T110).

    This poster presented additional data from Study 404, a Phase 3 clinical trial evaluating…

    Presentations highlight lumateperone's broad antidepressant effects in patients with bipolar disorder and in patients with schizophrenia with co-morbid depression

    NEW YORK, Dec. 09, 2020 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (NASDAQ:ITCI), a biopharmaceutical company focused on the development and commercialization of therapeutics for central nervous system (CNS) disorders, today announced two presentations at the 59th Annual Meeting of the American College of Neuropsychopharmacology (ACNP) being held virtually, December 6-9, 2020.

    • "Lumateperone (ITI-007) in the Treatment of Bipolar Depression: Efficacy Across Symptoms" (Poster T110).

    This poster presented additional data from Study 404, a Phase 3 clinical trial evaluating lumateperone as monotherapy for the treatment of patients with bipolar depression. In this Study, lumateperone 42 mg met its primary endpoint of change from baseline at day 43 on the Montgomery-Åsberg Depression Rating Scale (MADRS) total score versus placebo (p<.0001; effect size (ES) = 0.56).

    A prospective analysis demonstrated lumateperone 42 mg significantly improved each of the 10 individual MADRS items versus placebo (P<.05 to P<.0001) indicating treatment with lumateperone results in reductions in all depression symptom domains.

    Data presented also included the categorical shift in severity of depression symptoms as assessed by the MADRS single-item scores. Results showed a higher proportion of lumateperone patients than placebo patients had improvements in overall bipolar illness severity shifting from severe to moderate/mild or no illness. These findings are consistent with the broad antidepressant effects seen with lumateperone in our depression programs.

    About the Montgomery-Åsberg Depression Rating Scale¹

    The Montgomery-Åsberg Depression Rating Scale (MADRS) is a 10-item, validated rating scale used to diagnose and rate the severity of depressive episodes and is an accepted regulatory endpoint in clinical trials of depression.

    The scale includes questions on the following items: 1. Apparent sadness; 2. Reported sadness; 3. Inner tension; 4. Reduced sleep; 5. Reduced appetite; 6. Concentration difficulties; 7. Lassitude; 8. Inability to feel; 9. Pessimistic thoughts; and 10. Suicidal thoughts. Each item can be scored 0 (no abnormality) to 6 (severe) with the potential overall score ranging from 0 to 60.

    • "Efficacy of Lumateperone (ITI-007) in Depression Symptoms Associated with Schizophrenia" (Poster T148).

    This poster presented a post-hoc analysis from the lumateperone long-term safety study (Study 303) in patients with stable schizophrenia with comorbid depression (Calgary Depression Scale for Schizophrenia or CDSS score ≥6) who were switched from prior antipsychotics.

    In patients with schizophrenia, depression symptoms are highly prevalent, even in stable patients following antipsychotic treatment. Depression associated with schizophrenia is linked to poorer patient outcomes, including increased risk of relapse and suicidality, worse functioning, and decreased quality of life.

    In patients with stable schizophrenia and comorbid moderate-to-severe depression (CDSS≥6; n=80), lumateperone 42 mg significantly improved a broad range of depression symptoms. The mean baseline CDSS score in these patients was 7.6. Following one year of lumateperone 42 mg treatment, the mean CDSS score was reduced by 4.8 points (p=<.0001) to 2.4 points. Significant improvement compared with baseline was observed as early as Day 75, the first on-treatment CDSS assessment.

    In this one year study lumateperone 42 mg significantly reduced a broad range of depression symptoms and maintained effectiveness over the entire treatment period as assessed by the CDSS. Each of the nine individual items of the CDSS were also analyzed and demonstrated significant improvement (P<.05 to P<.0001) versus baseline at day 75 (the earliest assessment).

    Clinically meaningful reduction of depression symptoms (response defined as ≥50% reduction from baseline on the CDSS) was achieved in 50% of patients with comorbid depression at baseline.

    These results support the potential benefits of lumateperone 42 mg in treating depression symptoms associated with schizophrenia and advancing the development of lumateperone in a variety of depressive disorders.

    About the Calgary Depression Scale for Schizophrenia²

    Calgary Depression Scale for Schizophrenia (CDSS) is a 9-item, validated scale used specifically to assess depression in people with schizophrenia. The scale was developed from, and validated against, the Hamilton Depression Rating Scale (HDRS), Beck Depression Inventory (BDI), and the Brief Psychiatric Rating Scale (BPRS). The CDSS scale was also validated against the MADRS³. The scale uniquely distinguishes depressive symptoms from positive, negative, and extrapyramidal symptoms in patients with schizophrenia. The CDSS, therefore, is the most suitable measure of depression in schizophrenia when compared to other scales that do not reliably distinguish depression from other symptoms associated with schizophrenia.

    The scales include questions on the following items: 1. Depression; 2. Hopelessness; 3. Self-Depreciation; 4. Guilty Ideas of Reference; 5. Pathological Guilt 6. Morning Depression; 7. Early Wakening; 8. Suicide; and 9. Observed Depression. Each item can be scored 0 to 3 (Absent, Mild, Moderate, or Severe) with the potential overall score ranging from 0 to 27.

    ¹ Montgomery SA, Asberg M. "A new depression scale designed to be sensitive to change". British Journal of Psychiatry. 1979; 134 (4): 382–89.

    ² Addington D, Addington J, Schissel B. "A depression rating scale for schizophrenics". Schizophr Res. 1990;3 (4):247–251.

    ³ Lako et al. "A systematic review of instruments to measure depressive symptoms in patients with schizophrenia". Journal of Affective Disorders 140 (2012) 38–47.

    CAPLYTA® (lumateperone) is indicated for the treatment of schizophrenia in adults. CAPLYTA is available in 42 mg capsules.

    Important Safety Information

    Boxed Warning: Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. CAPLYTA is not approved for the treatment of patients with dementia-related psychosis.

    Contraindications: CAPLYTA is contraindicated in patients with known hypersensitivity to lumateperone or any components of CAPLYTA. Reactions have included pruritus, rash (e.g. allergic dermatitis, papular rash, and generalized rash), and urticaria.

    Warnings & Precautions: Antipsychotic drugs have been reported to cause:

    • Cerebrovascular Adverse Reactions in Elderly Patients with Dementia-Related Psychosis, including stroke and transient ischemic attack. See Boxed Warning above.
    • Neuroleptic Malignant Syndrome (NMS), which is a potentially fatal reaction. Signs and symptoms include: high fever, stiff muscles, confusion, changes in breathing, heart rate, and blood pressure, elevated creatinine phosphokinase, myoglobinuria (and/or rhabdomyolysis), and acute renal failure. Patients who experience signs and symptoms of NMS should immediately contact their doctor or go to the emergency room.
    • Tardive Dyskinesia, a syndrome of uncontrolled body movements in the face, tongue, or other body parts, which may increase with duration of treatment and total cumulative dose. TD may not go away, even if CAPLYTA is discontinued. It can also occur after CAPLYTA is discontinued.
    • Metabolic Changes, including hyperglycemia, diabetes mellitus, dyslipidemia, and weight gain. Hyperglycemia, in some cases extreme and associated with ketoacidosis, hyperosmolar coma or death, has been reported in patients treated with antipsychotics. Measure weight and assess fasting plasma glucose and lipids when initiating CAPLYTA and monitor periodically during long-term treatment.
    • Leukopenia, Neutropenia, and Agranulocytosis (including fatal cases). Complete blood counts should be performed in patients with pre-existing low white blood cell count (WBC) or history of leukopenia or neutropenia. CAPLYTA should be discontinued if clinically significant decline in WBC occurs in absence of other causative factors.
    • Decreased Blood Pressure & Dizziness. Patients may feel lightheaded, dizzy or faint when they rise too quickly from a sitting or lying position (orthostatic hypotension). Heart rate and blood pressure should be monitored and patients should be warned with known cardiovascular or cerebrovascular disease. Orthostatic vital signs should be monitored in patients who are vulnerable to hypotension.
    • Falls. CAPLYTA may cause sleepiness or dizziness and can slow thinking and motor skills, which may lead to falls and, consequently, fractures and other injuries. Patients should be assessed for risk when using CAPLYTA.
    • Seizures. CAPLYTA should be used cautiously in patients with a history of seizures or with conditions that lower seizure threshold.
    • Sleepiness and Trouble Concentrating. Patients should use caution when operating machinery or motor vehicles until they know how CAPLYTA affects them.
    • Body Temperature Dysregulation. CAPLYTA should be used with caution in patients who may experience conditions that may increase core body temperature such as strenuous exercise, extreme heat, dehydration, or concomitant anticholinergics.
    • Dysphagia. CAPLYTA should be used with caution in patients at risk for aspiration.

    Drug Interactions: CAPLYTA should not be used with CYP3A4 inducers, moderate or strong CYP3A4 inhibitors and UGT inhibitors.

    Special Populations: Newborn infants exposed to antipsychotic drugs during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery. Breastfeeding is not recommended. Use of CAPLYTA should be avoided in patients with moderate or severe liver problems.

    Adverse Reactions: The most common adverse reactions in clinical trials with CAPLYTA vs. placebo were somnolence/sedation (24% vs. 10%) and dry mouth (6% vs. 2%).

    Please see click here for full Prescribing Information, including Boxed Warning.

    CAPLYTA is a registered trademark of Intra-Cellular Therapies, Inc.

    © 2020 Intra-Cellular Therapies, Inc. All rights reserved. 3/2020 US-CAP-2000150

    About CAPLYTA (lumateperone)

    CAPLYTA 42mg/day is an oral, once daily atypical antipsychotic approved for the treatment of schizophrenia of adults. While the mechanism of action of CAPLYTA in the treatment of schizophrenia is unknown, the efficacy of CAPLYTA could be mediated through a combination of antagonist activity at central serotonin 5-HT2A receptors and postsynaptic antagonist activity at central dopamine D2 receptors.

    CAPLYTA (lumateperone) is being investigated for the treatment of bipolar depression, depression and other neuropsychiatric and neurological disorders. CAPLYTA is not FDA approved for these disorders.

    About Intra-Cellular Therapies

    Intra-Cellular Therapies is a biopharmaceutical company founded on Nobel prize-winning research that allows us to understand how therapies affect the inner-workings of cells in the body. The company leverages this intracellular approach to develop innovative treatments for people living with complex psychiatric and neurologic diseases.

    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 expectations regarding the potential benefits of lumateperone 42 mg in treating depression symptoms associated with schizophrenia and the potential to advance the development of lumateperone as a potential treatment for a variety of depressive disorders; our beliefs about the potential utility of our product candidates; 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: the COVID-19 pandemic may negatively impact the conduct of, and the timing of enrollment, completion and reporting with respect to, our clinical trials; any other impacts on our business as a result of or related to the COVID-19 pandemic; risks associated with our current and planned clinical trials; we may encounter unexpected safety or tolerability issues with CAPLYTA following commercial launch for the treatment of schizophrenia or in ongoing or future trials and other development activities; 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 or in clinical trials for other indications; 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



    212-213-0006

    MEDIA INQUIRIES:

    Ana Fullmer

    Corporate Media Relations W2Owcg



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  9. NEW YORK, Nov. 30, 2020 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (NASDAQ:ITCI), a biopharmaceutical company focused on the development and commercialization of therapeutics for central nervous system (CNS) disorders, today announced that Sharon Mates, Ph.D., Chief Executive Officer and Chairman, is scheduled to participate in a fireside chat at the Evercore ISI 3rd Annual HealthCONx Conference on Wednesday, December 2, 2020 at 9:15am ET.

    The live and archived webcast can be accessed under "Events & Presentations" in the Investor Relations section of the Company's website at www.intracellulartherapies.com. Please log in approximately 5-10 minutes prior to the event to register and to download and install any necessary software.

    NEW YORK, Nov. 30, 2020 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (NASDAQ:ITCI), a biopharmaceutical company focused on the development and commercialization of therapeutics for central nervous system (CNS) disorders, today announced that Sharon Mates, Ph.D., Chief Executive Officer and Chairman, is scheduled to participate in a fireside chat at the Evercore ISI 3rd Annual HealthCONx Conference on Wednesday, December 2, 2020 at 9:15am ET.

    The live and archived webcast can be accessed under "Events & Presentations" in the Investor Relations section of the Company's website at www.intracellulartherapies.com. Please log in approximately 5-10 minutes prior to the event to register and to download and install any necessary software.

    About Intra-Cellular Therapies

    Intra-Cellular Therapies is a biopharmaceutical company founded on Nobel prize-winning research that allows us to understand how therapies affect the inner-workings of cells in the body. The company leverages this intracellular approach to develop innovative treatments for people living with complex psychiatric and neurologic diseases. For more information, please visit www.intracellulartherapies.com.

    CONTACT:

    Intra-Cellular Therapies, Inc.

    Juan Sanchez, M.D.

    Vice President, Corporate Communications and Investor Relations

    646-440-9333

    Burns McClellan, Inc.

    Lisa Burns



    212-213-0006



    Primary Logo

    View Full Article Hide Full Article
  10. Positive topline results reported from Study ‘402, a Phase 3 Study evaluating lumateperone as an adjunctive treatment to lithium or valproate in patients with bipolar depression.

    Company is preparing sNDA for the treatment of bipolar depression for submission to the FDA. Study ‘402, in conjunction with our previously reported positive Phase 3 monotherapy study, Study 404, forms the basis for our sNDA.

    Strong CAPLYTA commercial performance with week-over-week and quarter-over-quarter prescription growth despite COVID-19 disruptions.

    Expanding lumateperone development in Major Depressive Disorder (MDD) and other depressive disorders and advancing a Long-Acting Injectable (LAI) formulation:

    A post-hoc analysis of Study ‘404, our global Phase

    Positive topline results reported from Study ‘402, a Phase 3 Study evaluating lumateperone as an adjunctive treatment to lithium or valproate in patients with bipolar depression.

    Company is preparing sNDA for the treatment of bipolar depression for submission to the FDA. Study ‘402, in conjunction with our previously reported positive Phase 3 monotherapy study, Study 404, forms the basis for our sNDA.

    Strong CAPLYTA commercial performance with week-over-week and quarter-over-quarter prescription growth despite COVID-19 disruptions.

    Expanding lumateperone development in Major Depressive Disorder (MDD) and other depressive disorders and advancing a Long-Acting Injectable (LAI) formulation:

    A post-hoc analysis of Study ‘404, our global Phase 3 study in bipolar depression, demonstrated that lumateperone was effective in the subset of patients presenting with mixed features in bipolar depression (p=0.003).

    Study ‘403 has been amended to evaluate lumateperone in patients with Bipolar depression and MDD with mixed features.

    Commencing two Phase 3 clinical studies evaluating lumateperone as an adjunctive therapy to antidepressants for the treatment of MDD.

    Following discussions with the FDA, initiating clinical studies of our lumateperone LAI subcutaneous formulation.

    NEW YORK, Nov. 09, 2020 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (NASDAQ:ITCI), a biopharmaceutical company focused on the development and commercialization of therapeutics for central nervous system (CNS) disorders, today announced its financial results for the third quarter ended September 30, 2020, and provided a corporate update.

    "Our Company is in a strong position. CAPLYTA is approved for the treatment of schizophrenia in adults and I am pleased with the prescription growth of CAPLYTA as we continue to provide this important medicine to patients.  In addition, we have a broad development plan for lumateperone in other major neuropsychiatric conditions.  We are soon submitting an sNDA for lumateperone for a second major indication, bipolar depression and initiating late stage studies in adjunctive MDD and in major depressive episodes with mixed features in patients with either bipolar disorder or MDD," said Dr. Sharon Mates, Chairman and CEO of Intra-Cellular Therapies.  "Our robust pipeline including our LAI formulation of lumateperone, ITI-214 and ITI-333 continue to advance and we are well capitalized to fund our commercial activities and development programs."

    CORPORATE UPDATE

    COMMERCIAL HIGHLIGHTS

    • Third quarter CAPLYTA results reflect strong commercial execution delivering continued robust week-over-week and quarter-over-quarter prescription growth; third quarter total prescriptions increased by approximately 280% versus the previous quarter. Our commercial organization continues to adapt to the dynamic COVID-19 environment and effectively engage with our prescribing audience through a mix of personal and non-personal activities. Importantly, healthcare practitioners' feedback on patient experience with CAPLYTA continues to be very positive.

    • CAPLYTA's market access continues to be strong with greater than 95% of covered lives in both Medicare Part D and State Medicaid, the major payer channels in schizophrenia. Our LytaLink program continues to support eligible patients' access pathway for CAPLYTA.

    CLINICAL HIGHLIGHTS

    Lumateperone - Bipolar Depression Program:

    • In September 2020, we reported positive topline results from Study 402, a Phase 3 clinical trial evaluating lumateperone as adjunctive therapy to lithium or valproate in the treatment of major depressive episodes associated with Bipolar I or Bipolar II disorder. Lumateperone 42 mg met the primary endpoint for improvement in depression as measured by change from baseline versus placebo on the MADRS total score (p=0.0206). Lumateperone 42 mg also met the key secondary endpoint, the CGI-BP-S Depression Score (p=0.0082). Lumateperone demonstrated a favorable safety profile and was generally well-tolerated in the trial. Rates of akathisia, restlessness, extrapyramidal symptoms, and changes in weight were similar to placebo, consistent with the safety profile demonstrated in our prior studies in schizophrenia and bipolar depression.

    • Study 402, in conjunction with our previously reported positive Phase 3 monotherapy study, Study 404, forms the basis for our supplemental new drug application (sNDA) for the treatment of bipolar depression in patients with Bipolar I or II disorder as monotherapy and adjunctive therapy. Our sNDA preparations remain on track and we expect to submit our application to the U.S. Food and Drug Administration (FDA) early in the first quarter of 2021 and anticipate an FDA target action date for the application in the second half of 2021. There are over 11 million adult Americans living with Bipolar disorder. Lumateperone has the potential to be the only approved treatment for bipolar depression in patients with either Bipolar I or Bipolar II disorder as an adjunctive treatment to mood stabilizers or as monotherapy.

    Lumateperone - Development in Major Depressive Disorder (MDD) and other depressive disorders and advancing a Long-Acting Injectable (LAI) formulation

    • We have amended our ongoing monotherapy bipolar depression study, Study 403, to focus on studying lumateperone in two patient populations: patients with MDD as well as patients with bipolar depression who present clinically with mixed features. This global study evaluates lumateperone 42 mg. The primary endpoint is change from baseline on the Montgomery–Åsberg Depression Rating Scale (MADRS) total score at week 6 versus placebo.



      In a post-hoc analysis of Study 404, in a subgroup of patients with bipolar depression with mixed features, lumateperone 42 mg had a statistically significant improvement from baseline on the MADRS total score versus placebo (p=0.003). These findings will be presented at future medical meetings.



      Approximately one third of patients with either MDD or bipolar depression can exhibit manic symptoms that are below the clinical threshold for mania or hypomania. These patients respond poorly to antidepressants, have greater symptom severity, have a higher risk of suicide attempts, and experience severe illness with more co-morbidities. The fifth edition of the Diagnostic and Statistical Manual of Mental Disorders or DSM-5 incorporates a mixed features specifier as a way to better characterize these patients.
    • We have commenced our Phase 3 clinical program evaluating lumateperone 42 mg as an adjunctive therapy to antidepressants for the treatment of MDD. Clinical conduct in two Phase 3 trials is anticipated to begin in 2021.

    Lumateperone Long Acting Injectable (LAI) formulation:

    • We recently completed a successful Type C meeting with the FDA. We plan to initiate clinical testing of our lumateperone long-acting injectable program later this year. An ascending single dose safety and pharmacokinetic (PK) study will be conducted followed by a multiple ascending dose safety and PK study administered subcutaneously.

    Other Programs

    • ITI-333: Based on a pre-IND meeting held with the FDA, we expect to initiate a single ascending dose safety and tolerability study evaluating ITI-333, our novel compound for the treatment of substance use disorders, in late 2020 or early 2021. We have received a grant from the National Institute on Drug Abuse as part of the NIH HEAL (Helping to End Addiction Long-term) initiative to support the early clinical development of ITI-333 for the treatment of opioid use disorder.

    Selected Third Quarter 2020 Financial Results

    The Company recorded net product sales of CAPLYTA for the third quarter of 2020 of approximately $7.4 million. No net product sales were reported for the comparable period of 2019.

    The Company reported a net loss of $55.2 million, or $0.79 per share (basic and diluted), for the third quarter of 2020 compared to a net loss of $34.9 million, or $0.63 per share (basic and diluted), for the third quarter of 2019.

    Research and development (R&D) expenses for the third quarter of 2020 were $10.3 million, compared to $21.3 million for the third quarter of 2019.  The $11.0 million decrease is due primarily to a decrease of approximately $6.2 million of lumateperone clinical and non-clinical costs, a decrease of approximately $2.9 million in research manufacturing costs and overhead, a decrease of $2.7 million for other projects, and is offset by an increase of $0.7 million for stock based compensation.

    Selling, general and administrative (SG&A) expenses were $52.5 million for the third quarter of 2020, compared to $15.0 million for the same period in 2019. Selling expenses were $38.3 million for the quarter ended September 30, 2020 as compared to pre-commercialization expenses of $6.4 million in the same period in 2019. This selling expense increase is primarily due to increases in sales related labor expenses of $15.4 million and commercialization and marketing expenses of $15.2 million. General and administrative expenses were $14.2 million in the quarter ended September 30, 2020 as compared to $8.6 million for the same period in 2019. This increase is due to increases in information technology expenses of $2.4 million, professional fees of $1.4 million, stock compensation expense of $1.4 million, labor and related expense of $0.4 million, and the remainder in other administrative expenses.

    Cash, cash equivalents, restricted cash and investment securities totaled $723.3 million at September 30, 2020, compared to $224.0 million at December 31, 2019.  In September 2020, the Company completed a public offering resulting in net proceeds to the Company of approximately $358 million, after deducting underwriting discounts and commissions and offering expenses, from the sale of 12.7 million shares of its common stock.  

    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 1859956. Please dial in approximately 10 minutes prior to the call.

    CAPLYTA™ (lumateperone) is indicated for the treatment of schizophrenia in adults. CAPLYTA is available in 42 mg capsules.

    Important Safety Information

    Boxed Warning: Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. CAPLYTA is not approved for the treatment of patients with dementia-related psychosis.

    Contraindications: CAPLYTA is contraindicated in patients with known hypersensitivity to lumateperone or any components of CAPLYTA. Reactions have included pruritus, rash (e.g. allergic dermatitis, papular rash, and generalized rash), and urticaria.

    Warnings & Precautions: Antipsychotic drugs have been reported to cause:

    • Cerebrovascular Adverse Reactions in Elderly Patients with Dementia-Related Psychosis, including stroke and transient ischemic attack. See Boxed Warning above.
    • Neuroleptic Malignant Syndrome (NMS), which is a potentially fatal reaction. Signs and symptoms include: high fever, stiff muscles, confusion, changes in breathing, heart rate, and blood pressure, elevated creatinine phosphokinase, myoglobinuria (and/or rhabdomyolysis), and acute renal failure. Patients who experience signs and symptoms of NMS should immediately contact their doctor or go to the emergency room.
    • Tardive Dyskinesia, a syndrome of uncontrolled body movements in the face, tongue, or other body parts, which may increase with duration of treatment and total cumulative dose. TD may not go away, even if CAPLYTA is discontinued. It can also occur after CAPLYTA is discontinued.
    • Metabolic Changes, including hyperglycemia, diabetes mellitus, dyslipidemia, and weight gain. Hyperglycemia, in some cases extreme and associated with ketoacidosis, hyperosmolar coma or death, has been reported in patients treated with antipsychotics. Measure weight and assess fasting plasma glucose and lipids when initiating CAPLYTA and monitor periodically during long-term treatment.
    • Leukopenia, Neutropenia, and Agranulocytosis (including fatal cases). Complete blood counts should be performed in patients with pre-existing low white blood cell count (WBC) or history of leukopenia or neutropenia. CAPLYTA should be discontinued if clinically significant decline in WBC occurs in absence of other causative factors.
    • Decreased Blood Pressure & Dizziness. Patients may feel lightheaded, dizzy or faint when they rise too quickly from a sitting or lying position (orthostatic hypotension). Heart rate and blood pressure should be monitored and patients should be warned with known cardiovascular or cerebrovascular disease. Orthostatic vital signs should be monitored in patients who are vulnerable to hypotension.
    • Falls. CAPLYTA may cause sleepiness or dizziness and can slow thinking and motor skills, which may lead to falls and, consequently, fractures and other injuries. Patients should be assessed for risk when using CAPLYTA.
    • Seizures. CAPLYTA should be used cautiously in patients with a history of seizures or with conditions that lower seizure threshold.
    • Sleepiness and Trouble Concentrating. Patients should use caution when operating machinery or motor vehicles until they know how CAPLYTA affects them.
    • Body Temperature Dysregulation. CAPLYTA should be used with caution in patients who may experience conditions that may increase core body temperature such as strenuous exercise, extreme heat, dehydration, or concomitant anticholinergics.
    • Dysphagia. CAPLYTA should be used with caution in patients at risk for aspiration.

    Drug Interactions: CAPLYTA should not be used with CYP3A4 inducers, moderate or strong CYP3A4 inhibitors and UGT inhibitors.

    Special Populations: Newborn infants exposed to antipsychotic drugs during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery. Breastfeeding is not recommended. Use of CAPLYTA should be avoided in patients with moderate or severe liver problems.

    Adverse Reactions: The most common adverse reactions in clinical trials with CAPLYTA vs. placebo were somnolence/sedation (24% vs. 10%) and dry mouth (6% vs. 2%).

    Please click here to see full Prescribing Information including Boxed Warning.

    About CAPLYTA (lumateperone)

    CAPLYTA 42mg/day is an oral, once daily atypical antipsychotic approved for the treatment of schizophrenia of adults. While the mechanism of action of CAPLYTA in the treatment of schizophrenia is unknown, the efficacy of CAPLYTA could be mediated through a combination of antagonist activity at central serotonin 5-HT2A receptors and postsynaptic antagonist activity at central dopamine D2 receptors.

    CAPLYTA (lumateperone) is being investigated for the treatment of bipolar depression, depression and other neuropsychiatric and neurological disorders. CAPLYTA is not FDA approved for these disorders.

    About Intra-Cellular Therapies

    Intra-Cellular Therapies is a biopharmaceutical company founded on Nobel prize-winning research that allows us to understand how therapies affect the inner-workings of cells in the body. The company leverages this intracellular approach to develop innovative treatments for people living with complex psychiatric and neurologic diseases. For more information, please visit www.intracellulartherapies.com.

    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 expectations regarding the commercialization of CAPLYTA; our plans and expected timing to submit an sNDA to the FDA for lumateperone for the treatment of bipolar depression and the anticipated timing of the FDA target action date for this sNDA, if accepted by the FDA; our plans and expected timing to initiate our lumateperone clinical studies in major depressive disorder; our plans and expected timing to initiate human testing of our lumateperone long-acting injectable program; our plans and expected timing to initiate early stage clinical studies for ITI-333; our development plans for our PDE program, including ITI-214; our beliefs about the potential utility of our product candidates; 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: there are no guarantees that CAPLYTA will be commercially successful; we may encounter issues, delays or other challenges in commercializing CAPLYTA; the COVID-19 pandemic may negatively impact our commercial plans and sales for CAPLYTA; the COVID-19 pandemic may negatively impact the conduct of, and the timing of enrollment, completion and reporting with respect to, our clinical trials; whether CAPLYTA receives adequate reimbursement from third-party payors; the degree to which CAPLYTA receives acceptance from patients and physicians for its approved indication; challenges associated with execution of our sales activities, which in each case could limit the potential of our product; results achieved in CAPLYTA in the treatment of schizophrenia following commercial launch of the product may be different than observed in clinical trials, and may vary among patients; any other impacts on our business as a result of or related to the COVID-19 pandemic; risks associated with our current and planned clinical trials; we may encounter unexpected safety or tolerability issues with CAPLYTA following commercial launch for the treatment of schizophrenia or in ongoing or future trials and other development activities; 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 or in clinical trials for other indications; 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



    212-213-0006

    MEDIA INQUIRIES:

    Ana Fullmer

    Corporate Media Relations W2Owcg



    202-507-0130



    INTRA-CELLULAR THERAPIES, INC.

    CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

    (Unaudited)

         
     Three Months Ended September 30,Nine Months Ended September 30,
     2020201920202019
    Revenues    
    Product sales, net        $7,368,594 $ $10,126,999 $ 
    Grant revenue             231,710   
    Total revenues, net         7,368,594    10,358,709   
    Operating expenses:          
    Cost of product sales         556,107    753,957   
    Research and development         10,275,368  21,339,792  51,483,551  70,059,113 
    Selling, general and administrative         52,473,573  15,036,444  128,015,496  42,184,078 
    Total operating expenses         63,305,048  36,376,236  180,253,004  112,243,191 
    Loss from operations         (55,936,454) (36,376,236) (169,894,295) (112,243,191)
    Interest income         752,829  1,513,837  3,591,091  5,105,464 
    Loss before provision for income taxes         (55,183,625) (34,862,399) (166,303,204) (107,137,727)
    Income tax expense             3,281  1,600 
           
    Net loss        $(55,183,625)$(34,862,399)$(166,306,485)$(107,139,327)
    Net loss per common share:          
    Basic & Diluted        $(0.79)$(0.63)$(2.48)$(1.94)
    Weighted average number of common shares:          
    Basic & Diluted         69,530,039  55,207,400  67,030,991  55,155,854 

    (1)   The condensed consolidated statements of operations for the three and nine months ended September 30, 2020 and 2019 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

       
     September 30,

    2020

    December 31,

    2019

     (Unaudited) 
    Assets  
    Current assets:  
    Cash and cash equivalents$300,988,981 $107,636,849 
    Investment securities, available-for-sale 420,958,509  116,373,335 
    Restricted cash 1,400,000   
    Accounts receivable, net 7,480,604   
    Inventory 2,947,138   
    Prepaid expenses and other current assets 11,090,774  6,313,785 
    Total current assets 744,866,006  230,323,969 
    Property and equipment, net 2,049,552  2,259,740 
    Right of use assets, net 24,292,167  18,252,074 
    Deferred tax asset, net —    264,609 
    Other assets 86,084  86,084 
    Total assets$771,293,809 $251,186,476 
    Liabilities and stockholders' equity  
    Current liabilities:  
    Accounts payable$8,569,148 $7,425,024 
    Accrued and other current liabilities 12,186,380  16,138,909 
    Lease liabilities, short-term 5,267,258  3,187,435 
    Accrued employee benefits 12,005,931  9,472,651 
    Total current liabilities 38,028,717  36,224,019 
    Lease liabilities 23,869,557  19,955,186 
    Total liabilities 61,898,274  56,179,205 
    Stockholders' equity:  
    Common stock, $0.0001 par value: 100,000,000 shares authorized; 80,142,797 and 55,507,497 shares issued and outstanding at September 30, 2020 and December 31, 2019, respectively 8,014  5,551 
    Additional paid-in capital 1,585,023,637  904,971,772 
    Accumulated deficit (876,404,854) (710,098,369)
    Accumulated comprehensive income 768,738  128,317 
    Total stockholders' equity 709,395,535  195,007,271 
    Total liabilities and stockholders' equity$771,293,809 $251,186,476 

    (1)   The condensed consolidated balance sheets at September 30, 2020 and December 31, 2019 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.



     

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  11. NEW YORK, Nov. 04, 2020 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (NASDAQ:ITCI), a biopharmaceutical company focused on the development of and commercialization of therapeutics for central nervous system (CNS) disorders, today announced that it will host a conference call and live webcast discussion at 8:30 a.m. Eastern Time on Monday, November 9, 2020, to provide a corporate update and discuss details of the Company's financial results for the quarter ended September 30, 2020.

    To access the live conference call via phone, dial 1-(844) 835-6563. The international dial-in number is 1-(970) 315-3916. The conference ID number for the live call is 1859956.

    The live and archived webcast can be accessed under "Events & Presentations…

    NEW YORK, Nov. 04, 2020 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (NASDAQ:ITCI), a biopharmaceutical company focused on the development of and commercialization of therapeutics for central nervous system (CNS) disorders, today announced that it will host a conference call and live webcast discussion at 8:30 a.m. Eastern Time on Monday, November 9, 2020, to provide a corporate update and discuss details of the Company's financial results for the quarter ended September 30, 2020.

    To access the live conference call via phone, dial 1-(844) 835-6563. The international dial-in number is 1-(970) 315-3916. The conference ID number for the live call is 1859956.

    The live and archived webcast can be accessed under "Events & Presentations" in the Investor Relations section of the Company's website at www.intracellulartherapies.com. Please log in approximately 5-10 minutes prior to the event to register and to download and install any necessary software.

    About Intra-Cellular Therapies

    Intra-Cellular Therapies is a biopharmaceutical company founded on Nobel prize-winning research that allows us to understand how therapies affect the inner-workings of cells in the body. The company leverages this intracellular approach to develop innovative treatments for people living with complex psychiatric and neurologic diseases.

    CONTACT:

    Intra-Cellular Therapies, Inc.

    Juan Sanchez, M.D.

    Vice President, Corporate Communications and Investor Relations

    646-440-9333

    Burns McClellan, Inc.

    Lisa Burns



    212-213-0006

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  12. NEW YORK, Oct. 2, 2020 /PRNewswire/ -- New Ventures Funds has launched a new corporate brand identity and changed its name to Scientia Ventures. The new website for the firm can be found at: www.scientiavc.com. This reflects the broadening of the firm's strategic direction since launching its 3rd fund in 2017 to reflect its focus on transformational science and technology in healthcare. The announcement follows two recent successful IPO's of portfolio companies: ADC Therapeutics (NYSE:ADCT) and Royalty Pharma (NASDAQ:RPRX); and successful Phase 3 clinical trials for two of its portfolio companies: FibroGen (NASDAQ:FGEN) and Intra-Cellular Therapies (NASDAQ:ITCI).

    NEW YORK, Oct. 2, 2020 /PRNewswire/ -- New Ventures Funds has launched a new corporate brand identity and changed its name to Scientia Ventures. The new website for the firm can be found at: www.scientiavc.com. This reflects the broadening of the firm's strategic direction since launching its 3rd fund in 2017 to reflect its focus on transformational science and technology in healthcare. The announcement follows two recent successful IPO's of portfolio companies: ADC Therapeutics (NYSE:ADCT) and Royalty Pharma (NASDAQ:RPRX); and successful Phase 3 clinical trials for two of its portfolio companies: FibroGen (NASDAQ:FGEN) and Intra-Cellular Therapies (NASDAQ:ITCI).

    Harry Glorikian, Partner, who leads the firm's work in digital systems explained: "We track and invest in the evolution of life sciences and healthcare systems. We are empowered by a combination of advances in the areas of information technology and biological data as applied to diagnostics and therapeutics. This is where we see the biggest impact for our investors and for the medical field. The name Scientia Ventures highlights our investment at what we believe is a major inflection point in these areas: the opportunity for industrialization of the technology and building successful companies." Harry Glorikian added: "If the difference between evolution and revolution is the speed of change, then healthcare now is in the mode of revolutionary change. This is creating unique opportunities in healthcare and the life sciences."

    "We are encouraged by the tremendous mindset shift that is going on as Big Pharma, biotech and healthcare startups all look at themselves not as biotech or healthcare but as data science companies. It is an exciting time for venture capital to make a difference," said Rory Riggs, a Founding Partner.

    "We believe this shift has the potential to revolutionize the drug development process, by reducing uncertainty, while generating unique intellectual property and allowing companies to bring breakthrough therapies to market more rapidly. Importantly, these therapies help patients get effective care and simultaneously drive down industry-wide costs," said Richard Warburg, Partner and leader of the firm's work on drug development.

    Commenting on the announcement, Jonathan Finn, CFA, a Founding Partner said, "This name change shows the strategic evolution of our firm. We continue to invest in transformative healthcare concepts and business models. Our strategy has evolved to parallel the change in technology."

    About Scientia Ventures

    Scientia Ventures invests in early to mid-stage technology companies that target computational biology and chemistry, the digitization of medicine, and digital therapies as well as traditional drug development companies at the cutting edge of the life sciences. Our strength is working with entrepreneurs and big ideas to build companies with the potential to transform healthcare. Our Partners, many of whom are former founders, operators, or CEO's of important healthcare companies, have a long history of working together and have domain expertise across healthcare, finance, and intellectual property.

    Contact:



    Scientia Ventures

    William Martin

    One Liberty Plaza

    Investor Relations

    46th Floor

    New York, NY 10006



    This is not an offer to purchase or sell, nor a solicitation of an offer to purchase or sell an interest in The Fund or any other financial instrument. Any offering or solicitation will be made only to qualified prospective investors pursuant to the offering memorandum, and the subscription documents, all of which should be read in their entirety.

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/new-ventures-funds-rebrands-as-scientia-ventures-301144560.html

    SOURCE Scientia Ventures

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  13. NEW YORK, Oct. 01, 2020 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (NASDAQ:ITCI), a biopharmaceutical company focused on the development and commercialization of therapeutics for central nervous system (CNS) disorders, today announced the promotion of Dr. Suresh Durgam to the position of Chief Medical Officer. Additionally, Dr. Andrew Satlin will step down as Chief Medical Officer, and will leave the Company effective October 28, 2020 to pursue a new opportunity. 

    "Dr. Durgam has a proven track record and deep expertise in neuropsychiatric drug development and has led our lumateperone clinical programs, including the schizophrenia and bipolar depression programs, while also playing a critical role in shaping our research and development…

    NEW YORK, Oct. 01, 2020 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (NASDAQ:ITCI), a biopharmaceutical company focused on the development and commercialization of therapeutics for central nervous system (CNS) disorders, today announced the promotion of Dr. Suresh Durgam to the position of Chief Medical Officer. Additionally, Dr. Andrew Satlin will step down as Chief Medical Officer, and will leave the Company effective October 28, 2020 to pursue a new opportunity. 

    "Dr. Durgam has a proven track record and deep expertise in neuropsychiatric drug development and has led our lumateperone clinical programs, including the schizophrenia and bipolar depression programs, while also playing a critical role in shaping our research and development strategy," said Dr. Sharon Mates, Chairman and CEO of Intra-Cellular Therapies.  "I look forward to continuing to work with him to advance our pipeline. Prior to joining Intra-Cellular Therapies, Dr. Durgam led the clinical development of the antipsychotic cariprazine, which received approval in schizophrenia and bipolar disorder. I would like to thank Dr. Satlin for his contributions to the Company and wish him continued success."  

    Dr. Durgam has served as Intra-Cellular Therapies Senior Vice President, Late Stage Clinical Development and Medical Affairs since joining the Company in 2018. He has been instrumental in the success of our schizophrenia and bipolar depression programs. Dr. Durgam, has over 23 years of experience in clinical research which includes over 17 years in neuropsychiatric drug development, including the development of antipsychotics and antidepressants.

    Dr. Durgam served in clinical development leadership roles at Forest Laboratories, Solvay and Allergan plc. He led programs across various indications including major depressive disorder, bipolar mania, bipolar depression, schizophrenia, cognitive impairment associated with schizophrenia, negative symptoms in schizophrenia, anxiety disorders, and pain. He has experience in the U.S. and globally in all phases of drug development from Phase I through Phase 4 studies. In addition to his role in the development of cariprazine and its approval in schizophrenia and bipolar disorder, Dr. Durgam oversaw studies with vilazodone, levomilancipran, and asenapine that led to sNDA fillings and supplemental approvals. He also led the major depressive disorder program with rapastinel and onabotulinumtoxinA for depression.

    Dr. Durgam graduated with his medical degree from the Siddhartha Medical College in India and received his residency training in psychiatry at Scott & White Clinic and Hospital – Texas A&M University System College of Medicine.

    About Intra-Cellular Therapies

    Intra-Cellular Therapies is a biopharmaceutical company founded on Nobel prize-winning research that allows us to understand how therapies affect the inner-workings of cells in the body. The company leverages this intracellular approach to develop innovative treatments for people living with complex psychiatric and neurologic diseases.

    Contact

    Intra-Cellular Therapies, Inc.

    Juan Sanchez, M.D.

    Vice President, Corporate Communications and Investor Relations

    646-440-9333

    Burns McClellan, Inc.

    Lisa Burns



    212-213-0006

    Media Inquiries:

    Ana Fullmer

    Corporate Media Relations W20wcg



    202-507-0130

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  14. NEW YORK, Sept. 15, 2020 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (NASDAQ:ITCI), a biopharmaceutical company focused on the development and commercialization of therapeutics for central nervous system (CNS) disorders, today announced that Sharon Mates, Ph.D., Chief Executive Officer and Chairman, is scheduled to participate in a fireside chat at the Morgan Stanley 18th Annual Global Healthcare Conference on Wednesday, September 16, 2020 at 2:00 pm ET.

    The live and archived webcast can be accessed under "Events & Presentations" in the Investor Relations section of the Company's website at www.intracellulartherapies.com. Please log in approximately 5-10 minutes prior to the event to register and to download and install any necessary…

    NEW YORK, Sept. 15, 2020 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (NASDAQ:ITCI), a biopharmaceutical company focused on the development and commercialization of therapeutics for central nervous system (CNS) disorders, today announced that Sharon Mates, Ph.D., Chief Executive Officer and Chairman, is scheduled to participate in a fireside chat at the Morgan Stanley 18th Annual Global Healthcare Conference on Wednesday, September 16, 2020 at 2:00 pm ET.

    The live and archived webcast can be accessed under "Events & Presentations" in the Investor Relations section of the Company's website at www.intracellulartherapies.com. Please log in approximately 5-10 minutes prior to the event to register and to download and install any necessary software.

    About Intra-Cellular Therapies

    Intra-Cellular Therapies is a biopharmaceutical company founded on Nobel prize-winning research that allows us to understand how therapies affect the inner-workings of cells in the body. The company leverages this intracellular approach to develop innovative treatments for people living with complex psychiatric and neurologic diseases.

    Contact

    Intra-Cellular Therapies, Inc.

    Juan Sanchez, M.D.

    Vice President, Corporate Communications and Investor Relations

    646-440-9333

    Burns McClellan, Inc.

    Lisa Burns



    212-213-0006

    Media Inquiries:

    Ana Fullmer

    Corporate Media Relations W20wcg



    202-507-0130

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  15. NEW YORK, Sept. 14, 2020 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (NASDAQ:ITCI), a biopharmaceutical company focused on the development and commercialization of therapeutics for central nervous system (CNS) disorders, today announced that Sharon Mates, Ph.D., Chief Executive Officer and Chairman, is scheduled to participate in a fireside chat at the Cantor Virtual Global Healthcare Conference on Tuesday, September 15, 2020 at 10:00 am ET.

    The live and archived webcast can be accessed under "Events & Presentations" in the Investor Relations section of the Company's website at www.intracellulartherapies.com. Please log in approximately 5-10 minutes prior to the event to register and to download and install any necessary software…

    NEW YORK, Sept. 14, 2020 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (NASDAQ:ITCI), a biopharmaceutical company focused on the development and commercialization of therapeutics for central nervous system (CNS) disorders, today announced that Sharon Mates, Ph.D., Chief Executive Officer and Chairman, is scheduled to participate in a fireside chat at the Cantor Virtual Global Healthcare Conference on Tuesday, September 15, 2020 at 10:00 am ET.

    The live and archived webcast can be accessed under "Events & Presentations" in the Investor Relations section of the Company's website at www.intracellulartherapies.com. Please log in approximately 5-10 minutes prior to the event to register and to download and install any necessary software.

    About Intra-Cellular Therapies

    Intra-Cellular Therapies is a biopharmaceutical company founded on Nobel prize-winning research that allows us to understand how therapies affect the inner-workings of cells in the body. The company leverages this intracellular approach to develop innovative treatments for people living with complex psychiatric and neurologic diseases.

    Contact

    Intra-Cellular Therapies, Inc.

    Juan Sanchez, M.D.

    Vice President, Corporate Communications and Investor Relations

    646-440-9333

    Burns McClellan, Inc.

    Lisa Burns



    212-213-0006

    Media Inquiries:

    Ana Fullmer

    Corporate Media Relations W20wcg



    202-507-0130

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  16. NEW YORK, Sept. 10, 2020 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (NASDAQ:ITCI), a biopharmaceutical company, today announced the pricing of its previously announced underwritten public offering of 11,666,667 shares of its common stock at a public offering price of $30.00 per share. All of the shares in the offering will be sold by Intra-Cellular Therapies, with gross proceeds to Intra-Cellular Therapies expected to be $350 million from the offering of an aggregate of 11,666,667 shares before deducting underwriting discounts and commissions and offering expenses. Intra-Cellular Therapies has granted the underwriters a 30-day option to purchase up to an additional 1,750,000 shares on the same terms and conditions. The offering is…

    NEW YORK, Sept. 10, 2020 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (NASDAQ:ITCI), a biopharmaceutical company, today announced the pricing of its previously announced underwritten public offering of 11,666,667 shares of its common stock at a public offering price of $30.00 per share. All of the shares in the offering will be sold by Intra-Cellular Therapies, with gross proceeds to Intra-Cellular Therapies expected to be $350 million from the offering of an aggregate of 11,666,667 shares before deducting underwriting discounts and commissions and offering expenses. Intra-Cellular Therapies has granted the underwriters a 30-day option to purchase up to an additional 1,750,000 shares on the same terms and conditions. The offering is expected to close on September 15, 2020, subject to the satisfaction of customary closing conditions.

    J.P. Morgan Securities LLC, Goldman Sachs & Co. LLC, SVB Leerink LLC and Evercore Group L.L.C. are acting as joint book-running managers for the offering. Cantor Fitzgerald & Co. and Canaccord Genuity LLC are acting as co-lead managers for the offering.

    The public offering is being made pursuant to a shelf registration statement on Form S-3 that was previously filed with the Securities and Exchange Commission (the "SEC") and became effective upon filing. A preliminary prospectus supplement and accompanying base prospectus relating to and describing the terms of the offering has been filed with the SEC and is available on the SEC's website located at http://www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to this offering, when available, can be obtained from J.P. Morgan Securities LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by telephone at 1-866-803-9204, or by email at , Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, by telephone at 1-866-471-2526, or by email at , SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at 1-800-808-7525, ext. 6132, or by email at , or Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 36th Floor, New York, NY 10055, by telephone at (888) 474-0200, or by email at .

    This press release shall not constitute an offer to sell, or a solicitation of an offer to buy, nor will there be any sale of these securities in any state or other jurisdiction in which such an offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

    About Intra-Cellular Therapies

    Intra-Cellular Therapies is a biopharmaceutical company founded on Nobel prize-winning research that allows us to understand how therapies affect the inner-workings of cells in the body. The company leverages this intracellular approach to develop innovative treatments for people living with complex psychiatric and neurologic diseases.

    Forward-Looking Statements

    This press release includes "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements, other than statements of historical fact, regarding, among other things, the completion and timing of the public offering and the anticipated total gross proceeds from the offering. Intra-Cellular Therapies often uses words such as "anticipates," "believes," "plans," "expects," "projects," "future," "intends," "may," "will," "should," "could," "estimates," "predicts," "potential," "planned," "continue," "guidance," and similar expressions to identify forward-looking statements. Actual results, performance or experience may differ materially from those expressed or implied by any forward-looking statement as a result of various risks, uncertainties and other factors, including, but not limited to: the completion of the public offering and other risks and uncertainties that are described under the heading "Risk Factors" in Intra-Cellular Therapies' preliminary prospectus supplement filed with the SEC on September 9, 2020, Intra-Cellular Therapies' most recent Annual Report on Form 10-K or in subsequent filings that it makes with the Securities and Exchange Commission. As a result of risks and uncertainties that Intra-Cellular Therapies faces, the results or events indicated by any forward-looking statement may not occur. Intra-Cellular Therapies cautions you not to place undue reliance on any forward-looking statement. In addition, any forward-looking statement in this press release represents Intra-Cellular Therapies' views only as of the date of this press release and should not be relied upon as representing its views as of any subsequent date. Intra-Cellular Therapies disclaims any obligation to update any forward-looking statement, except as required by applicable 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



    212-213-0006

    Media Inquiries:

    Ana Fullmer

    Corporate Media Relations W20wcg



    202-507-0130

    Primary Logo

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  17. NEW YORK, Sept. 09, 2020 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (NASDAQ:ITCI), a biopharmaceutical company, today announced that it has commenced an underwritten public offering of $350 million of shares of its common stock. In connection with the offering, Intra-Cellular Therapies intends to grant the underwriters a 30-day option to purchase up to an additional 15% of the shares of common stock offered in the public offering. All of the shares in the offering will be sold by Intra-Cellular Therapies.

    J.P. Morgan Securities LLC, Goldman Sachs & Co. LLC, SVB Leerink LLC and Evercore Group L.L.C. are acting as joint book-running managers for the offering. The offering is subject to market and other conditions, and there can be no…

    NEW YORK, Sept. 09, 2020 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (NASDAQ:ITCI), a biopharmaceutical company, today announced that it has commenced an underwritten public offering of $350 million of shares of its common stock. In connection with the offering, Intra-Cellular Therapies intends to grant the underwriters a 30-day option to purchase up to an additional 15% of the shares of common stock offered in the public offering. All of the shares in the offering will be sold by Intra-Cellular Therapies.

    J.P. Morgan Securities LLC, Goldman Sachs & Co. LLC, SVB Leerink LLC and Evercore Group L.L.C. are acting as joint book-running managers for the offering. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

    The public offering will be made pursuant to a shelf registration statement on Form S-3 that was previously filed with the Securities and Exchange Commission (the "SEC") and became effective upon filing. A preliminary prospectus supplement and accompanying base prospectus relating to and describing the terms of the offering will be filed with the SEC and will be available on the SEC's website located at http://www.sec.gov. The offering is being made only by means of a prospectus and related prospectus supplement, copies of which may be obtained from J.P. Morgan Securities LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by telephone at 1-866-803-9204, or by email at , Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, by telephone at 1-866-471-2526, or by email at , SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at 1-800-808-7525, ext. 6132, or by email at , or Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 36th Floor, New York, NY 10055, by telephone at (888) 474-0200, or by email at . The final terms of the offering will be disclosed in a final prospectus supplement to be filed with the SEC.

    This press release shall not constitute an offer to sell, or a solicitation of an offer to buy, nor will there be any sale of these securities in any state or other jurisdiction in which such an offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

    About Intra-Cellular Therapies

    Intra-Cellular Therapies is a biopharmaceutical company founded on Nobel prize-winning research that allows us to understand how therapies affect the inner-workings of cells in the body. The company leverages this intracellular approach to develop innovative treatments for people living with complex psychiatric and neurologic diseases.

    Forward-Looking Statements

    This press release includes "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements, other than statements of historical fact, regarding, among other things, the proposed public offering of common stock. Intra-Cellular Therapies often uses words such as "anticipates," "believes," "plans," "expects," "projects," "future," "intends," "may," "will," "should," "could," "estimates," "predicts," "potential," "planned," "continue," "guidance," and similar expressions to identify forward-looking statements. Actual results, performance or experience may differ materially from those expressed or implied by any forward-looking statement as a result of various risks, uncertainties and other factors, including, but not limited to: uncertainties related to market conditions and the completion of the public offering on the anticipated terms or at all, and other risks and uncertainties that are described under the heading "Risk Factors" in Intra-Cellular Therapies' preliminary prospectus supplement to be filed with the SEC, Intra-Cellular Therapies' most recent Annual Report on Form 10-K or in subsequent filings that it makes with the Securities and Exchange Commission. As a result of risks and uncertainties that Intra-Cellular Therapies faces, the results or events indicated by any forward-looking statement may not occur. Intra-Cellular Therapies cautions you not to place undue reliance on any forward-looking statement. In addition, any forward-looking statement in this press release represents Intra-Cellular Therapies' views only as of the date of this press release and should not be relied upon as representing its views as of any subsequent date. Intra-Cellular Therapies disclaims any obligation to update any forward-looking statement, except as required by applicable 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



    212-213-0006

    Media Inquiries:

    Ana Fullmer

    Corporate Media Relations W20wcg



    202-507-0130

    Primary Logo

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  18. Lumateperone 42 mg achieved statistically significant results in primary and key secondary endpoints in Study 402. Company expects to submit supplemental new drug application (sNDA) to the U.S. Food and Drug Administration (FDA) in late 2020 or early 2021.

    Lumateperone 42 mg met the primary endpoint of change from baseline at Week 6 on the Montgomery-Åsberg Depression Rating Scale (MADRS) total score versus placebo (p=0.0206).

    Lumateperone 42 mg also met the key secondary objective on the Clinical Global Impression Scale for Bipolar for Severity of Illness- Depression subscale (CGI-BP-S) (p=0.0082).

    Favorable safety and tolerability profile observed, consistent with all prior lumateperone trials. Rates of akathisia, restlessness, extrapyramidal

    Lumateperone 42 mg achieved statistically significant results in primary and key secondary endpoints in Study 402. Company expects to submit supplemental new drug application (sNDA) to the U.S. Food and Drug Administration (FDA) in late 2020 or early 2021.

    Lumateperone 42 mg met the primary endpoint of change from baseline at Week 6 on the Montgomery-Åsberg Depression Rating Scale (MADRS) total score versus placebo (p=0.0206).

    Lumateperone 42 mg also met the key secondary objective on the Clinical Global Impression Scale for Bipolar for Severity of Illness- Depression subscale (CGI-BP-S) (p=0.0082).

    Favorable safety and tolerability profile observed, consistent with all prior lumateperone trials. Rates of akathisia, restlessness, extrapyramidal symptoms and changes in weight were similar to placebo.

    This study, in conjunction with our previously reported positive Phase 3 monotherapy study, Study 404, forms the basis for our sNDA for the treatment of bipolar depression in patients with Bipolar I or II disorder as monotherapy and adjunctive therapy.

    Conference call scheduled today at 8:00 a.m. ET

    NEW YORK, Sept. 09, 2020 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (NASDAQ:ITCI), a biopharmaceutical company focused on the development and commercialization of therapeutics for central nervous system (CNS) disorders, today announced positive topline results from its Phase 3 clinical trial (Study 402) evaluating lumateperone as adjunctive therapy to lithium or valproate in the treatment of major depressive episodes associated with Bipolar I or Bipolar II disorder. In Study 402, once daily lumateperone 42 mg met the primary endpoint for improvement in depression as measured by change from baseline versus placebo on the MADRS total score (p=0.0206; effect size = 0.27). Lumateperone 42 mg also met the key secondary endpoint, the CGI-BP-S Depression Score (p=0.0082; effect size = 0.31). The lower lumateperone dose, 28 mg, showed a trend for a dose-related improvement in symptoms of depression but the results did not reach statistical significance. Lumateperone demonstrated a favorable safety profile and was generally well-tolerated in the trial. The most commonly reported adverse events that were observed at a rate greater than or equal to 5% and at least twice the rate of placebo were somnolence, dizziness, and nausea. Rates of akathisia, restlessness, extrapyramidal symptoms, and changes in weight were similar to placebo. This trial, in conjunction with our previously reported positive Phase 3 monotherapy study, Study 404, forms the basis for our sNDA for the treatment of bipolar depression in patients with Bipolar I or II disorder as monotherapy and adjunctive therapy which we expect to submit to the FDA in late 2020 or early 2021.

    "Our program now has confirmatory evidence of efficacy and a favorable safety and tolerability profile of lumateperone in bipolar depression; we look forward to submitting our supplemental NDA to expand lumateperone's label to include a second major neuropsychiatric disorder," said Dr. Sharon Mates, Chairman and CEO of Intra-Cellular Therapies. "With this clinical milestone, lumateperone has shown further potential to benefit patients suffering from a range of serious mental health conditions in addition to schizophrenia."

    "Bipolar disorders are serious and complex mental health conditions that affect millions of people, and depression is the most common presentation of these disorders. In this study, lumateperone demonstrated a robust effect, which is particularly significant considering patients were maintained on lithium or valproate," said Dr. Roger McIntyre, Professor of Psychiatry and Pharmacology at the University of Toronto and Head of the Mood Disorders Psychopharmacology Unit at the University Health Network, Toronto, Canada. "Lumateperone is the first treatment to demonstrate efficacy for bipolar depression as monotherapy and as adjunctive therapy to mood stabilizers in a study population including both Bipolar I and Bipolar II patients. This will be welcome news to the psychiatric community as there is a tremendous need for improved treatment options."

    About Study 402

    Study 402 was conducted globally in five countries including in the U.S. A total of 529 patients with moderate to severe major depressive episodes associated with either Bipolar I or Bipolar II disorder were randomized 1:1:1 to lumateperone 42 mg, 28 mg or placebo, while being maintained on lithium or valproate as mood stabilizers.

    Lumateperone 42 mg met the primary endpoint by demonstrating a statistically significant improvement compared to placebo at week 6 (trial endpoint), as measured by change from baseline on the MADRS total score. In the intent-to-treat (ITT) study population, the least squares (LS) mean reduction from baseline for lumateperone 42 mg was 16.9 points, versus 14.5 points for placebo (LS mean difference = 2.4 points; effect size = 0.27, p=0.0206).

    Lumateperone 42 mg also met the key secondary endpoint of statistically significant improvement on the CGI-BP-S Depression Score (p=0.0082; effect size = 0.31).

    Lumateperone 28 mg showed a trend for a dose-related improvement in symptoms of depression. Though not formally tested against placebo since it did not separate on the primary endpoint, lumateperone 28 mg demonstrated a statistically significant improvement versus placebo on the CGI-BP-S.

    Lumateperone was generally well-tolerated with a favorable safety profile in the trial. Adverse events were mostly mild to moderate and similar to those seen in prior studies in bipolar depression and schizophrenia, with no new adverse events observed. These findings provide further evidence supporting lumateperone's favorable safety and tolerability profile across different patient populations.

    Conference Call and Webcast Details

    Intra-Cellular Therapies will host a live conference call and webcast today at 8:00 a.m. ET, during which management will discuss the topline results of Study 402. 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 2980818. Please dial in approximately 10 minutes prior to the call.

    About Lumateperone

    Pharmacodynamics studies have shown lumateperone acts as a potent antagonist with high binding affinity at serotonin 5-HT2A receptors, as an antagonist with moderate binding affinity at postsynaptic D2 receptors, an inhibitor of the reuptake of serotonin transporter (SERT) with moderate biding affinity, and a partial agonist with moderate affinity at D1 receptors (which may contribute to the indirect activation of AMPA and NMDA receptors). These receptors are believed to play an important role in in schizophrenia, bipolar disorder, depressive disorders and other neuropsychiatric disorders. In vitro studies have shown lumateperone has a ~60-fold greater affinity for 5-HT2A receptors compared to D2 receptors.

    Lumateperone is being investigated for the treatment of bipolar depression, depression and other neuropsychiatric and neurological disorders. Lumateperone is not FDA approved for these disorders. CAPLYTA 42 mg (lumateperone) is approved by the FDA for the treatment schizophrenia of adults.

    About Bipolar Depression

    Bipolar I and Bipolar II disorder are serious, highly prevalent psychiatric conditions, affecting approximately 6 million adults in the United States, or about 2.8% of the U.S. population.

    These disorders are characterized by recurrent episodes of mania or hypomania interspersed with episodes of major depression known as Bipolar depression. Bipolar I and Bipolar II each represent about half of the overall population of patients with bipolar disorder.

    Bipolar depression is the most common clinical presentation of bipolar disorder. These episodes tend to last longer, recur more often, and are associated with a worse prognosis than the manic/hypomanic episodes. Bipolar depression remains a significantly underserved medical need, with only a few FDA-approved treatment options available. These treatments are commonly associated with tolerability issues.

    About Intra-Cellular Therapies

    Intra-Cellular Therapies is a biopharmaceutical company founded on Nobel prize-winning research that allows us to understand how therapies affect the inner-workings of cells in the body. The company leverages this intracellular approach to develop innovative treatments for people living with complex psychiatric and neurologic diseases. For more information, please visit www.intracellulartherapies.com.

    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, the safety, tolerability and efficacy of our product candidates; the potential for lumateperone to receive FDA approval for treatment of bipolar depression in patients with Bipolar I or II disorder as monotherapy and adjunctive therapy; our expectation that we will submit an sNDA, based on Study 402 and Study 404, for the treatment of bipolar depression in patients with Bipolar I or II disorder as monotherapy and adjunctive therapy to the FDA in late 2020 or early 2021; the potential for lumateperone to represent an advancement for the treatment of bipolar depression; 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: we may encounter issues or other challenges in commercializing CAPLYTA for the treatment of schizophrenia, including but not limited to negative impacts from the COVID-19 pandemic, ongoing pricing negotiations with certain payors that have not finalized their assessments, and performance of our sales activity, and that results achieved in CAPLYTA in the treatment of schizophrenia may be different than observed in clinical trials and may vary among patients; any other impacts on our business as a result of or related to the COVID-19 pandemic; there can be no guarantee that the sNDA for lumateperone for the treatment of bipolar depression will be submitted within the target timelines or that the sNDA will be approved by the FDA without a request for the submission of additional information or at all; 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



    212-213-0006

    MEDIA INQUIRIES:

    Ana Fullmer

    Corporate Media Relations W2Owcg



    202-507-0130

    Primary Logo

    View Full Article Hide Full Article
  19. NEW YORK, Aug. 10, 2020 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (NASDAQ:ITCI), a biopharmaceutical company focused on the development and commercialization of therapeutics for central nervous system (CNS) disorders, today announced its financial results for the second quarter ended June 30, 2020, and provided a corporate update.

    "We have completed our first full quarter of commercial activities, adapting to the unprecedented challenges of the COVID-19 pandemic, and I am encouraged by CAPLYTA's week over week prescription growth and increasing prescriber base," said Dr. Sharon Mates, Chairman and CEO of Intra-Cellular Therapies.  "I am pleased with our team's performance in the current environment, the positive physician response…

    NEW YORK, Aug. 10, 2020 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (NASDAQ:ITCI), a biopharmaceutical company focused on the development and commercialization of therapeutics for central nervous system (CNS) disorders, today announced its financial results for the second quarter ended June 30, 2020, and provided a corporate update.

    "We have completed our first full quarter of commercial activities, adapting to the unprecedented challenges of the COVID-19 pandemic, and I am encouraged by CAPLYTA's week over week prescription growth and increasing prescriber base," said Dr. Sharon Mates, Chairman and CEO of Intra-Cellular Therapies.  "I am pleased with our team's performance in the current environment, the positive physician response to CAPLYTA and the impact we are making in the lives of patients suffering from schizophrenia. We are also excited about advancements in our pipeline, including the upcoming announcement of results from our Phase 3 clinical trial evaluating lumateperone as an adjunctive treatment in bipolar depression (Study 402) and the continued progress in our other pipeline programs."

    CORPORATE UPDATE

    COMMERCIAL HIGHLIGHTS

    • CAPLYTA promotional activities for the treatment of schizophrenia in adults commenced the week of March 30, 2020. Our commercial organization quickly adapted to the challenges to the healthcare industry and patient care brought by COVID-19.

       
    • Following a successful virtual launch, our neuroscience sales specialists are actively engaging with healthcare providers educating on CAPLYTA. We have been effectively engaging with our prescribing audience through a mix of personal and non-personal promotion including both remote, and more recently, live in-person interactions with our sales team, peer to peer medical education, journal advertising, virtual conferences & product theatre presentations and digital marketing efforts.

       
    • CAPLYTA has now achieved formulary coverage for greater than 95% of covered lives in both Medicare Part D and State Medicaid, our two largest channels. We continue to see coverage determination improvements in the commercial payer channel with final coverage expected to be established by the end of this year.



    • We are launching our new consumer campaign called "Real Progress". The purpose of the campaign is to educate patients and caregivers about CAPLYTA and to open the dialogue about optimizing care and treatment options. "Real Progress" includes a national direct-to-consumer (or DTC) television advertising campaign and accompanying social media campaign, as well as a partnership with a leading telepsychiatry platform.



    • Our LYTAlink patient access and affordability program is fully operational and performing as planned. The program offerings consist of coverage and reimbursement services, out-of-pocket copay support for commercially insured patients, medication compliance communications, and patient assistance relief specifically for eligible patients without insurance.

    CLINICAL HIGHLIGHTS

    • Lumateperone in Bipolar Depression: Study 402, our Phase 3 study evaluating lumateperone as adjunctive therapy in bipolar depression, has completed clinical conduct and we anticipate reporting topline results from this study by mid-September 2020.  This global study enrolled patients with major depressive episodes associated with either Bipolar I or Bipolar II disorder, who were randomized (1:1:1) to receive lumateperone 42 mg, 28 mg or placebo once daily for six weeks, while being maintained on lithium or valproate as mood stabilizers. The primary endpoint is change from baseline on the Montgomery–Åsberg Depression Rating Scale (MADRS) total score at week 6.



      Study 403, a Phase 3 global study evaluating lumateperone 42 mg as monotherapy in the treatment of depression in patients with Bipolar I or Bipolar II disorder, is ongoing. We anticipate reporting top-line results from this study in the second half of 2021.     
    • ITI-214 in Heart Failure: We reported positive results from our Phase 1/2 clinical trial of ITI-214, our phosphodiesterase 1 (PDE1) inhibitor, in patients with chronic systolic heart failure.  This study evaluated the hemodynamic profile and safety of single ascending doses of ITI-214. In the study, ITI-214 improved cardiac output both by increasing heart contractility and by decreasing vascular resistance, that is, ITI-214 functions as an inodilator. The improvement in cardiac output was not associated with the development of arrhythmias in patients. Details of these results will be presented at upcoming medical conferences.



    • Other Clinical Programs: We plan to initiate our lumateperone clinical program in major depressive disorder later this year. In addition, we expect to initiate human testing of our lumateperone long-acting injectable program later this year. We also expect to initiate early stage clinical studies for ITI-333, our novel, oral modulator of mu opioid and serotonin receptors for the treatment of opioid and other substance use disorders, pain, and mood disorders.

    Selected Second Quarter 2020 Financial Results



    The Company recorded net product sales of CAPLYTA for the second quarter of 2020 of approximately $1.9 million. No net product sales were reported for the comparable period of 2019.

    The Company reported a net loss of $63.7 million, or $0.96 per share (basic and diluted), for the second quarter of 2020 compared to a net loss of $37.4 million, or $0.68 per share (basic and diluted), for the second quarter of 2019.

    Research and development (R&D) expenses for the second quarter of 2020 were $25.2 million, compared to $23.7 million for the second quarter of 2019.  The $1.5 million increase is primarily due to an increase of approximately $9.2 million of lumateperone clinical costs and an increase of approximately $0.6 million in stock compensation expense and overhead expenses and is offset by a decrease of approximately $5.3 million of manufacturing costs, and a decrease of approximately $3.0 million for non-clinical related efforts.

    Selling, general and administrative (SG&A) expenses were $41.4 million for the second quarter of 2020, compared to $15.4 million for the same period in 2019. The increase of $26.0 million is due to an increase of $20.6 million for selling related costs and an increase of $5.4 million for general and administrative costs. The increase in selling related costs is due primarily to hiring a sales force, resulting in an increase in labor expenses of $15.0 million and commercialization and marketing costs of $5.0 million. The increase in general and administrative costs is due primarily to an increase in labor related expenses of $2.3 million, information technology expenses of $1.5 million, and professional fees of $1.0 million.

    Cash, cash equivalents, restricted cash and investment securities totaled $409.2 million at June 30, 2020, compared to $224.0 million at December 31, 2019. In January 2020, the Company completed a $295.0 million public offering resulting in net proceeds to the Company of approximately $277.0 million from the sale of 10 million shares of its common stock, after deducting underwriting discounts and commissions and offering expenses paid by the Company.   

    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 1574586. Please dial in approximately 10 minutes prior to the call.

    CAPLYTA™ (lumateperone) is indicated for the treatment of schizophrenia in adults. CAPLYTA is available in 42 mg capsules.

    Important Safety Information

    Boxed Warning: Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. CAPLYTA is not approved for the treatment of patients with dementia-related psychosis.

    Contraindications: CAPLYTA is contraindicated in patients with known hypersensitivity to lumateperone or any components of CAPLYTA. Reactions have included pruritus, rash (e.g. allergic dermatitis, papular rash, and generalized rash), and urticaria.

    Warnings & Precautions: Antipsychotic drugs have been reported to cause:

    • Cerebrovascular Adverse Reactions in Elderly Patients with Dementia-Related Psychosis, including stroke and transient ischemic attack. See Boxed Warning above.
    • Neuroleptic Malignant Syndrome (NMS), which is a potentially fatal reaction. Signs and symptoms include: high fever, stiff muscles, confusion, changes in breathing, heart rate, and blood pressure, elevated creatinine phosphokinase, myoglobinuria (and/or rhabdomyolysis), and acute renal failure. Patients who experience signs and symptoms of NMS should immediately contact their doctor or go to the emergency room. 
    • Tardive Dyskinesia, a syndrome of uncontrolled body movements in the face, tongue, or other body parts, which may increase with duration of treatment and total cumulative dose. TD may not go away, even if CAPLYTA is discontinued. It can also occur after CAPLYTA is discontinued.
    • Metabolic Changes, including hyperglycemia, diabetes mellitus, dyslipidemia, and weight gain. Hyperglycemia, in some cases extreme and associated with ketoacidosis, hyperosmolar coma or death, has been reported in patients treated with antipsychotics. Measure weight and assess fasting plasma glucose and lipids when initiating CAPLYTA and monitor periodically during long-term treatment.
    • Leukopenia, Neutropenia, and Agranulocytosis (including fatal cases). Complete blood counts should be performed in patients with pre-existing low white blood cell count (WBC) or history of leukopenia or neutropenia. CAPLYTA should be discontinued if clinically significant decline in WBC occurs in absence of other causative factors.
    • Decreased Blood Pressure & Dizziness. Patients may feel lightheaded, dizzy or faint when they rise too quickly from a sitting or lying position (orthostatic hypotension). Heart rate and blood pressure should be monitored and patients should be warned with known cardiovascular or cerebrovascular disease. Orthostatic vital signs should be monitored in patients who are vulnerable to hypotension.
    • Falls. CAPLYTA may cause sleepiness or dizziness and can slow thinking and motor skills, which may lead to falls and, consequently, fractures and other injuries. Patients should be assessed for risk when using CAPLYTA.
    • Seizures. CAPLYTA should be used cautiously in patients with a history of seizures or with conditions that lower seizure threshold.
    • Sleepiness and Trouble Concentrating. Patients should use caution when operating machinery or motor vehicles until they know how CAPLYTA affects them.
    • Body Temperature Dysregulation. CAPLYTA should be used with caution in patients who may experience conditions that may increase core body temperature such as strenuous exercise, extreme heat, dehydration, or concomitant anticholinergics.
    • Dysphagia. CAPLYTA should be used with caution in patients at risk for aspiration.

    Drug Interactions: CAPLYTA should not be used with CYP3A4 inducers, moderate or strong CYP3A4 inhibitors and UGT inhibitors.

    Special Populations: Newborn infants exposed to antipsychotic drugs during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery. Breastfeeding is not recommended. Use of CAPLYTA should be avoided in patients with moderate or severe liver problems.

    Adverse Reactions: The most common adverse reactions in clinical trials with CAPLYTA vs. placebo were somnolence/sedation (24% vs. 10%) and dry mouth (6% vs. 2%).

    Please click here to see full Prescribing Information including Boxed Warning.

    About CAPLYTA (lumateperone)

    CAPLYTA 42mg/day is an oral, once daily atypical antipsychotic approved for the treatment of schizophrenia of adults. While the mechanism of action of CAPLYTA in the treatment of schizophrenia is unknown, the efficacy of CAPLYTA could be mediated through a combination of antagonist activity at central serotonin 5-HT2A receptors and postsynaptic antagonist activity at central dopamine D2 receptors.

    CAPLYTA (lumateperone) is being investigated for the treatment of bipolar depression, depression and other neuropsychiatric and neurological disorders. CAPLYTA is not FDA approved for these disorders.

    About Intra-Cellular Therapies

    Intra-Cellular Therapies is a biopharmaceutical company founded on Nobel prize-winning research that allows us to understand how therapies affect the inner-workings of cells in the body. The company leverages this intracellular approach to develop innovative treatments for people living with complex psychiatric and neurologic diseases. For more information, please visit www.intracellulartherapies.com.

    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 expectations regarding the commercialization of CAPLYTA; our expectations about coverage of CAPLYTA by payors; our plans and the expected timing for the availability and reporting of data from our ongoing Phase 3 trials in bipolar depression; our plans and expected timing to initiate our lumateperone clinical program in major depressive disorder; our plans and expected timing to initiate human testing of our lumateperone long-acting injectable program; our plans and expected timing to initiate early stage clinical studies for ITI-333; our development plans for our PDE program, including ITI-214; our beliefs about the potential utility of our product candidates; 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: there are no guarantees that CAPLYTA will be commercially successful; we may encounter issues, delays or other challenges in commercializing CAPLYTA; the COVID-19 pandemic may negatively impact our commercial plans and sales for CAPLYTA; the COVID-19 pandemic may negatively impact the conduct of, and the timing of enrollment, completion and reporting with respect to, our clinical trials; whether CAPLYTA receives adequate reimbursement from third-party payors; the degree to which CAPLYTA receives acceptance from patients and physicians for its approved indication; challenges associated with execution of our sales activities, which in each case could limit the potential of our product; results achieved in CAPLYTA in the treatment of schizophrenia following commercial launch of the product may be different than observed in clinical trials, and may vary among patients; any other impacts on our business as a result of or related to the COVID-19 pandemic; risks associated with our current and planned clinical trials; we may encounter unexpected safety or tolerability issues with CAPLYTA following commercial launch for the treatment of schizophrenia or in ongoing or future trials and other development activities; 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 or in clinical trials for other indications; 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



    212-213-0006

    MEDIA INQUIRIES:

    Ana Fullmer

    Corporate Media Relations W2Owcg



    202-507-0130

    INTRA-CELLULAR THERAPIES, INC.

    CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

    (Unaudited)

     Three Months Ended June 30,  Six Months Ended June 30, 
     2020  2019  2020  2019 
    Revenues                
    Product sales, net$  1,875,889  $  $2,758,405  $ 
    Grant revenue 30,747       —   231,710    
    Total revenues 1,906,636      2,990,115    
                    
    Operating expenses:  
    Cost of product sales  128,539      197,850    
    Research and development  25,204,857   23,728,464   41,208,183   48,719,321 
    Selling, general and administrative  41,445,557   15,442,650   75,541,923   27,147,634 
    Total operating expenses  66,778,953   39,171,114   116,947,956   75,866,955 
    Loss from operations  (64,872,317  (39,171,114  (113,957,841  (75,866,955
    Interest income  1,160,059   1,731,550   2,838,262   3,591,627 
    Loss before provision for income taxes  (63,712,258  (37,439,564  (111,119,579  (72,275,328
    Income tax expense     1,600   3,281   1,600 
    Net loss $(63,712,258 $(37,441,164 $(111,122,860 $(72,276,928
                    
    Net loss per common share:       
    Basic & Diluted $(0.96 $(0.68 $(1.69 $(1.31
    Weighted average number of common shares:       
    Basic & Diluted  66,429,371   55,145,901   65,767,737   55,129,654 

    (1) The condensed consolidated statements of operations for the quarters ended June 30, 2020 and 2019 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

         
     June 30,

    2020
     

     December 31,

    2019  
     
         
     (Unaudited)

      
    Assets  
    Current assets:  
    Cash and cash equivalents$  129,290,445 $  107,636,849 
    Investment securities, available-for-sale   278,468,502    116,373,335 
    Restricted cash   1,400,000    — 
    Accounts receivable, net   2,353,255    — 
    Inventory   2,335,042    — 
    Prepaid expenses and other current assets   4,726,134    6,313,785 
    Total current assets   418,573,378    230,323,969 
    Property and equipment, net   2,000,687    2,259,740 
    Right of use assets, net   20,270,675    18,252,074 
    Deferred tax asset, net   —    264,609 
    Other assets   86,084    86,084 
    Total assets$  440,930,824 $  251,186,476 
           
       
    Liabilities and stockholders' equity  
    Current liabilities:  
    Accounts payable$  5,472,987 $  7,425,024 
    Accrued and other current liabilities   19,383,111    16,138,909 
    Lease liabilities, short-term   3,973,920    3,187,435 
    Accrued employee benefits   11,412,697    9,472,651 
    Total current liabilities   40,242,715    36,224,019 
    Lease liabilities   21,158,241    19,955,186 
           
    Total liabilities   61,400,956    56,179,205 
    Stockholders' equity:  
    Common stock, $0.0001 par value: 100,000,000 shares authorized; 66,777,737 and 55,507,497 shares issued and outstanding at June 30, 2020 and December 31, 2019, respectively   6,678    5,551 
    Additional paid-in capital   1,199,576,320    904,971,772 
    Accumulated deficit   (821,221,229)   (710,098,369)
    Accumulated comprehensive income   1,168,099    128,317 
    Total stockholders' equity   379,529,868    195,007,271 
    Total liabilities and stockholders' equity$  440,930,824 $  251,186,476 
           
       

    (1) The condensed consolidated balance sheets at June 30, 2020 and December 31, 2019 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.

     

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  20. NEW YORK, Aug. 04, 2020 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (NASDAQ:ITCI), a biopharmaceutical company focused on the development of and commercialization of therapeutics for central nervous system (CNS) disorders, today announced that it will host a conference call and live webcast discussion at 8:30 a.m. Eastern Time on Monday, August 10, 2020, to provide a corporate update and discuss details of the Company's financial results for the quarter ended June 30, 2020.

    To access the live conference call via phone, dial 1-(844) 835-6563. The international dial-in number is 1-(970) 315-3916. The conference ID number for the live call is 1574586.

    The live and archived webcast can be accessed under "Events & Presentations" in the…

    NEW YORK, Aug. 04, 2020 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (NASDAQ:ITCI), a biopharmaceutical company focused on the development of and commercialization of therapeutics for central nervous system (CNS) disorders, today announced that it will host a conference call and live webcast discussion at 8:30 a.m. Eastern Time on Monday, August 10, 2020, to provide a corporate update and discuss details of the Company's financial results for the quarter ended June 30, 2020.

    To access the live conference call via phone, dial 1-(844) 835-6563. The international dial-in number is 1-(970) 315-3916. The conference ID number for the live call is 1574586.

    The live and archived webcast can be accessed under "Events & Presentations" in the Investor Relations section of the Company's website at www.intracellulartherapies.com. Please log in approximately 5-10 minutes prior to the event to register and to download and install any necessary software.

    About Intra-Cellular Therapies

    Intra-Cellular Therapies is a biopharmaceutical company founded on Nobel prize-winning research that allows us to understand how therapies affect the inner-workings of cells in the body. The company leverages this intracellular approach to develop innovative treatments for people living with complex psychiatric and neurologic diseases. For more information, please visit www.intracellulartherapies.com.

    CONTACT:

    Intra-Cellular Therapies, Inc.

    Juan Sanchez, M.D.

    Vice President, Corporate Communications and Investor Relations

    646-440-9333

    Burns McClellan, Inc.

    Lisa Burns



    212-213-0006

    Primary Logo

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  21. Study demonstrated inhibiting phosphodiesterase-1 with ITI-214 in patients with heart failure improved cardiac function by enhancing cardiac contractility and dilating systemic arteries without inducing abnormal heart rhythms.

    NEW YORK, June 29, 2020 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (NASDAQ:ITCI) today announced topline results from Study ITI-214-104, a Phase I/II translational study of single ascending doses of ITI-214, a novel, selective phosphodiesterase-1 (PDE1) inhibitor, in patients with chronic systolic heart failure with reduced ejection fraction (HFrEF). ITI-214 is the first PDE1 inhibitor to be tested in patients with HFrEF.

    In this study, ITI-214 improved cardiac output by increasing heart contractility and decreasing…

    Study demonstrated inhibiting phosphodiesterase-1 with ITI-214 in patients with heart failure improved cardiac function by enhancing cardiac contractility and dilating systemic arteries without inducing abnormal heart rhythms.

    NEW YORK, June 29, 2020 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (NASDAQ:ITCI) today announced topline results from Study ITI-214-104, a Phase I/II translational study of single ascending doses of ITI-214, a novel, selective phosphodiesterase-1 (PDE1) inhibitor, in patients with chronic systolic heart failure with reduced ejection fraction (HFrEF). ITI-214 is the first PDE1 inhibitor to be tested in patients with HFrEF.

    In this study, ITI-214 improved cardiac output by increasing heart contractility and decreasing vascular resistance. Agents that both increase heart contractility (inotropism) and decrease vascular resistance (vasodilation) are called inodilators. Inodilators in current clinical use are associated with the development of arrhythmias, which are abnormal heart rhythms that when serious can impair heart function and lead to mortality.  ITI-214, which acts through a novel mechanism of action, was not associated with arrhythmias in this study and was generally well tolerated in all patients.

    The results of Study ITI-214-104 are consistent with our prior findings in preclinical models of heart failure and indicate that single-dose administration of ITI-214 can improve heart function in patients with HFrEF. These findings warrant further investigation of acute and chronic PDE-1 inhibition with ITI-214 in this patient population.

    "ITI-214 improved the strength of heart contraction on top of lowering blood pressure stress on the heart.  This occurred without impacting arrhythmia in patients with heart failure.  These exciting results support a novel mechanism of action, and suggest that inhibition of the PDE-1 enzyme concurrent with standard-of-care may benefit heart failure patients without incurring the risks associated with inodilators in current clinical use," said David Kass, M.D., the Abraham and Virginia Weiss Professor of Cardiology at Johns Hopkins University School of Medicine, who was involved in the study.

    "Based on these findings, ITI-214 has the potential to be a safe, once-a-day oral inodilator with a novel mechanism of action that could have utility in clinical situations where there is great unmet medical need, ranging from the treatment of acute heart failure to the maintenance of patients with stable chronic HFrEF," said Sharon Mates, Ph.D., Chairman and CEO of Intra-Cellular Therapies, Inc. 

    The initiation of Study ITI-214-104 followed findings in preclinical models that ITI-214 had improved cardiac output through a mechanism of action different from those of available heart failure therapies.  These findings in preclinical models of heart failure were published by researchers at Johns Hopkins University and Intra-Cellular Therapies scientists in the journal Circulation1.  Currently available heart failure drugs that strengthen heart contractions, such as PDE3 inhibitors (amrinone and milrinone) and ß-adrenergic agonists (dobutamine), are associated with potentially dangerous complications, such as arrhythmias. ITI-214 does not interact with the ß-adrenergic signaling pathway and does not stimulate abnormal rhythms in an animal model of heart failure.  These experimental results demonstrated that ITI-214 may exert its effects via distinct pathways, one of which involves adenosine A2B receptor signaling, and suggest that ITI-214 may represent a mechanistically novel and potentially safe approach for the treatment of human heart failure.

    About Study ITI-214-104

    Study ITI-214-104 was a randomized, double-blind, placebo-controlled study of escalating single oral doses of ITI-214 (10, 30, and 90 mg) in patients with HFrEF NYHA class II-III.  The primary objective of the study was to determine the effects of ITI-214 on cardiac function, using echocardiography with Doppler imaging, in patients with reduced ejection fraction (≤35%) who were already maintained on standard-of-care treatment.  Safety was evaluated by monitoring for hemodynamic effects and changes in cardiac rhythm.

    Thirty-five patients were enrolled in this study, 9 in each of three dose cohorts and 8 in the placebo arm. The mean age of the patients was 54; 57% were male, and 57% were black. The etiology of the heart failure was ischemic heart disease in 31% of the patients. The mean left ventricular ejection fraction at screening was 25%. 

    In this study, compared to placebo, single doses of ITI-214 increased mean left ventricular (LV) power index and cardiac output while systemic vascular resistance and mean arterial blood pressure decreased. Reported adverse events were all mild to moderate and consisted of three occurrences of orthostatic hypotension and three episodes of non-postural hypotension. Patients were monitored by continuous telemetry, and no changes in heart rhythms were noted. No serious adverse events were reported. Further details of these results will be presented at upcoming medical conferences.

    About Heart Failure



    According to the U.S. Centers for Disease Control and Prevention, heart failure affects about 6.5 million adults in the United States and contributes to an estimated one in eight deaths.  Heart failure is a chronic condition marked by weakening of the heart muscle that leads to shortness of breath and general body weakness that worsens with physical exertion. There is no cure for heart failure, and there is significant unmet need, particularly for safe agents that can both increase the strength of the heart as well as reduce vascular afterload.

    Currently available heart failure drugs that can improve the contractile strength of the heart muscle, such as the PDE3 inhibitors amrinone and milrinone, and the β-adrenergic agonist dobutamine, increase cyclic AMP and thereby increase intracellular calcium in cardiac muscle cells.  Both approaches are associated with safety risks, most notably arrhythmia.

    PDE1 inhibition also modifies cyclic AMP, but it does so in a different manner linked with a novel intracellular pathway that involves adenosine A2B receptor signaling but not ß-adrenergic signaling to stimulate heart contractility. ITI-214 did not cause calcium levels to rise in cardiomyocyte cells. In all of the studies to date, activation of the PDE1-regulated pathway has not triggered arrhythmia.

    About ITI-214

    ITI-214 is a potent and selective phosphodiesterase type 1 (PDE1) inhibitor. ITI-214 is the lead compound in the Company's PDE1 portfolio and is in development for the treatment of symptoms associated with Parkinson's disease and for the treatment of heart failure. ITI-214 has been generally well tolerated with a favorable safety profile in six Phase 1 clinical trials. ITI-214 works by slowing the breakdown of cyclic nucleotides (cAMP, cGMP), thus allowing these molecules to build up in the cells and to exert important functions. The PDE1 enzyme is highly active in pathological or disease states, and our PDE1 molecules are designed to reestablish normal function in these disease states through the inhibition of the PDE1 enzyme.

    In heart disease, excessive PDE1 activity may limit the beneficial effects of cAMP or cGMP, so inhibitors like ITI-214 have the potential to act as a therapy. ITI-214 is an inodilator that can improve cardiac function by both increasing the force of heart contractions and reducing the resistance to pushing blood through the vascular system. Preclinical research has shown that ITI-214 increases cardiac contractility and decreases vascular resistance without increasing abnormal heart rhythms, and the clinical results announced herein indicate that similar, potentially therapeutic physiologic effects can be attained in heart failure patients. ITI-214 is being developed for the potential treatment of heart failure with reduced ejection fraction (HFrEF).

    Previous studies have described the mechanism of action of ITI-214 in the brain. The mechanism of action of ITI-214 and our other PDE1 inhibitors suggests therapeutic potential across a variety of diseases including neurological and cardiovascular diseases.

    1. Bui AL, et al. Nat Rev Cardiol. 2011;8: 30-41. 2. Hashimoto et al., Circulation 138:1974-1987 (2018)

    About Intra-Cellular Therapies

    Intra-Cellular Therapies is a biopharmaceutical company founded on Nobel prize-winning research that allows us to understand how therapies affect the inner-workings of cells in the body. The company leverages this intracellular approach to develop innovative treatments for people living with complex psychiatric and neurologic diseases. For more information, please visit www.intracellulartherapies.com.

    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, the therapeutic value, clinical and non-clinical development plans and commercial potential of our drug product candidates; the progress, timing and results of our clinical trials and preclinical studies; our beliefs about the extent to which the results of our clinical trials and preclinical studies to date support new drug application filings for product candidates; the safety and efficacy of our product development candidates; our beliefs about the potential uses and benefits of our drug product candidates; the potential for ITI-214 to represent a novel approach for the treatment of human heart failure; that ITI-214 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 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 our 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; the COVID-19 pandemic may negatively impact the conduct of, and the timing of enrollment, completion and reporting with respect to, our clinical trials; any other impacts on our business as a result of or related to the COVID-19 pandemic; 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



    212-213-0006

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  22. NEW YORK, May 14, 2020 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (NASDAQ:ITCI), a biopharmaceutical company focused on the development and commercialization of therapeutics for central nervous system (CNS) disorders, today announced that Sharon Mates, Ph.D., Chief Executive Officer and Chairman, is scheduled to present at the 2020 RBC Capital Markets Global Healthcare Conference. The presentation is scheduled for Tuesday, May 19, 2020 at 9:10 am ET.

    The live and archived webcast can be accessed under "Press Releases & Events" in the Investor Relations section of the Company's website at www.intracellulartherapies.com. Please log in approximately 5-10 minutes prior to the event to register and to download and install any necessary software…

    NEW YORK, May 14, 2020 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (NASDAQ:ITCI), a biopharmaceutical company focused on the development and commercialization of therapeutics for central nervous system (CNS) disorders, today announced that Sharon Mates, Ph.D., Chief Executive Officer and Chairman, is scheduled to present at the 2020 RBC Capital Markets Global Healthcare Conference. The presentation is scheduled for Tuesday, May 19, 2020 at 9:10 am ET.

    The live and archived webcast can be accessed under "Press Releases & Events" in the Investor Relations section of the Company's website at www.intracellulartherapies.com. Please log in approximately 5-10 minutes prior to the event to register and to download and install any necessary software.

    About Intra-Cellular Therapies

    Intra-Cellular Therapies is a biopharmaceutical company founded on Nobel prize-winning research that allows us to understand how therapies affect the inner-workings of cells in the body. The company leverages this intracellular approach to develop innovative treatments for people living with complex psychiatric and neurologic diseases. For more information, please visit www.intracellulartherapies.com.

    Contact

    Intra-Cellular Therapies, Inc.
    Juan Sanchez, M.D.
    Vice President, Corporate Communications and Investor Relations
    646-440-9333

    Burns McClellan, Inc.
    Lisa Burns

    212-213-0006

    MEDIA INQUIRIES:

    Ana Fullmer
    Corporate Media Relations W2Owcg

    202-507-0130

    Source: Intra-Cellular Therapies Inc.

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  23. NEW YORK, May 13, 2020 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (NASDAQ:ITCI), a biopharmaceutical company focused on the development and commercialization of therapeutics for central nervous system (CNS) disorders, today announced that it will hold its 2020 Annual Meeting of Stockholders (the "Annual Meeting") virtually due to the public health impact of the coronavirus (COVID-19) pandemic and to prioritize the health and well-being of meeting participants.

    The Annual Meeting will be held in a virtual-only format on May 27, 2020, at 10:00 a.m., Eastern Time. Stockholders will not be able to attend the Annual Meeting in person, however, stockholders of record and registered beneficial owners as of the close of business on April 6…

    NEW YORK, May 13, 2020 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (NASDAQ:ITCI), a biopharmaceutical company focused on the development and commercialization of therapeutics for central nervous system (CNS) disorders, today announced that it will hold its 2020 Annual Meeting of Stockholders (the "Annual Meeting") virtually due to the public health impact of the coronavirus (COVID-19) pandemic and to prioritize the health and well-being of meeting participants.

    The Annual Meeting will be held in a virtual-only format on May 27, 2020, at 10:00 a.m., Eastern Time. Stockholders will not be able to attend the Annual Meeting in person, however, stockholders of record and registered beneficial owners as of the close of business on April 6, 2020, will be able to vote and ask questions during the meeting through the online platform.

    Attending the Virtual Annual Meeting

    Stockholders can attend the meeting by accessing www.meetingcenter.io/238568156 and entering the 15-digit control number found on their proxy card, voting instruction form, notice of internet availability of proxy materials, or email previously received. Stockholders may vote during the Annual Meeting by following the instructions available on the meeting website during the meeting.

    A support line will be available on the meeting website shortly prior to, and during, the Annual Meeting to assist stockholders with any technical difficulties they may have accessing or hearing the virtual meeting.

    Participating, Voting Electronically and Submitting Questions at the Virtual Annual Meeting

    Stockholders of Record

    Stockholders of record will be able to participate in the Annual Meeting, vote electronically and submit questions during the live webcast of the meeting, without advance registration. The two items of information needed to access the live webcast of the meeting are the following:

    Computershare Control Number: the 15-digit control number found on your proxy card, voting instruction form, notice of internet availability of proxy materials, or email you previously received

    Meeting password: ITCI2020 

    Beneficial Owners

    If you are a beneficial owner and hold your shares through an intermediary, such as a bank, broker or nominee, you must register in advance to participate in the Annual Meeting, vote electronically and submit questions during the live webcast of the meeting. To register in advance you must obtain a legal proxy from the bank, broker or other nominee that holds your shares giving you the right to vote the shares. You must forward a copy of the legal proxy along with your email address to Computershare Trust Company, N.A. ("Computershare").

    Requests for registration should be directed to Computershare by email at no later than 10:00 a.m. Eastern Time, on Tuesday, May 26, 2020. You will receive a confirmation of your registration and instructions on how to attend the meeting by email after Computershare receives your registration materials.

    Stockholders may also submit questions in advance of the Annual Meeting by emailing your question, along with proof of ownership, to . The Company will, subject to time constraints, answer all questions that are pertinent to the business of the Annual Meeting.

    About Intra-Cellular Therapies

    Intra-Cellular Therapies is a biopharmaceutical company founded on Nobel prize-winning research that allows it to understand how therapies affect the inner-workings of cells in the body. The Company leverages this intracellular approach to develop innovative treatments for people living with complex psychiatric and neurologic diseases. For more information, please visit www.intracellulartherapies.com.

    Contact

    Intra-Cellular Therapies, Inc.
    Juan Sanchez, M.D.
    Vice President, Corporate Communications and Investor Relations
    646-440-9333

    Burns McClellan, Inc.
    Lisa Burns
     
    212-213-0006

    MEDIA INQUIRIES:

    Ana Fullmer
    Corporate Media Relations W2Owcg

    202-507-0130

    Primary Logo

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  24. NEW YORK, May 07, 2020 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (NASDAQ:ITCI), a biopharmaceutical company focused on the development and commercialization of therapeutics for central nervous system (CNS) disorders, today announced its financial results for the first quarter ended March 31, 2020, and provided a corporate update.

    "In the midst of these unprecedented times we are proud of the agile adaptation of our organization to successfully execute a virtual launch of CAPLYTA, a new treatment option for adult patients suffering from schizophrenia," said Dr. Sharon Mates, Chairman and CEO of Intra-Cellular Therapies. "Beyond our commercial efforts, we also continue to make progress in the advancement of our development programs…

    NEW YORK, May 07, 2020 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (NASDAQ:ITCI), a biopharmaceutical company focused on the development and commercialization of therapeutics for central nervous system (CNS) disorders, today announced its financial results for the first quarter ended March 31, 2020, and provided a corporate update.

    "In the midst of these unprecedented times we are proud of the agile adaptation of our organization to successfully execute a virtual launch of CAPLYTA, a new treatment option for adult patients suffering from schizophrenia," said Dr. Sharon Mates, Chairman and CEO of Intra-Cellular Therapies. "Beyond our commercial efforts, we also continue to make progress in the advancement of our development programs, having completed patient enrollment in our Phase 3 clinical trial evaluating lumateperone as an adjunctive treatment in bipolar depression (Study 402) and clinical conduct in our proof-of-mechanism (Phase I/II) study evaluating ITI-214 in patients with heart failure."

    CORPORATE UPDATE

    COMMERCIAL HIGHLIGHTS

    • Successful Launch of CAPLYTA
       
      • Comprehensive promotional activities for CAPLYTA commenced the week of March 30, 2020, following U.S. Food and Drug Administration (FDA) approval of CAPLYTA for the treatment of schizophrenia in adults in December 2019. The efficacy of CAPLYTA 42 mg was demonstrated in two placebo-controlled trials, showing a statistically significant benefit over placebo on the primary endpoint, the Positive and Negative Syndrome Scale (PANSS) total score. In pooled data from short term studies, mean changes from baseline in weight, fasting glucose, triglycerides and total cholesterol were similar between CAPLYTA and placebo. The incidence of extrapyramidal symptoms was similar to placebo.
         
      • Successful completion of a 100% virtual national launch meeting, after onboarding our neuroscience sales specialists that were hired in the first quarter of 2020. The vast majority of our specialists have prior psychiatry medication sales experience, including antipsychotics. After successful completion of our virtual national launch meeting, our neuroscience sales specialists are now actively engaging healthcare providers with the goal of providing comprehensive education on CAPLYTA. Our sales specialists are equipped with remote product presentation and sampling capability. These activities are being complemented by virtual peer-to peer medical education and expanded digital outreach programs.  

      • Substantial progress in our market access coverage determinations with payers and we are pleased with the coverage achieved to date.
         
      • Introducing LYTAlink: In support of patient access and affordability we have also introduced LYTAlink, a comprehensive patient support program designed to provide a number of access and affordability offerings to eligible CAPLYTA patients. The program offerings consist of coverage and reimbursement services, out-of-pocket copay support for commercially insured patients, medication compliance communications, and patient assistance relief specifically for eligible patients without insurance.

      • Manufacturing and supply chain related activities are in place and are supporting commercial demand for CAPLYTA. We have substantial product supply in the U.S. with long expiry dating to support expected demand.

    CLINICAL HIGHLIGHTS

    • Lumateperone in Bipolar Depression: We have completed patient enrollment in Study 402, our Phase 3 study evaluating lumateperone as adjunctive therapy in bipolar depression, and anticipate reporting topline results from this study in mid-2020. 
    • ITI-214 in Heart Failure: Clinical conduct in our Phase 1/2 clinical trial of ITI-214, our phosphodiesterase 1 (PDE1) inhibitor, in patients with chronic systolic heart failure has been completed.  This study evaluates the hemodynamic profile and safety of single ascending doses of ITI-214. We anticipate reporting topline results from this trial in the second quarter of 2020.

    • Other Clinical Programs: We are continuing necessary activities to advance our other development programs and to ensure patient safety in accordance with recent FDA guidelines for clinical trial conduct in the COVID-19 pandemic environment. These programs include our lumateperone clinical program in major depressive disorder, our long-acting injectable program of lumateperone, our ITI-214 program in Parkinson's disease and the initiation of early stage clinical studies for ITI-333, our novel, oral modulator of mu opioid and serotonin receptors for the treatment of opioid and other substance use disorders, pain, and mood disorders. We will provide additional updates on our clinical programs as the current environment evolves.

    Selected First Quarter 2020 Financial Results

    The Company recorded net product sales of CAPLYTA for the first quarter of 2020 of approximately $882,500. No net product sales were reported for the comparable period of 2019.

    The Company reported a net loss of $47.4 million, or $0.73 per share (basic and diluted), for the first quarter of 2020 compared to a net loss of $34.8 million, or $0.63 per share (basic and diluted), for the first quarter of 2019.

    Research and development (R&D) expenses for the first quarter of 2020 were $16.0 million, compared to $25.0 million for the first quarter of 2019.  The $9.0 million decrease is primarily due to lower clinical and non-clinical related costs for lumateperone, manufacturing costs, and is partially offset by higher non-lumateperone related project costs and higher labor costs in the first quarter of 2020.

    Selling, general and administrative (SG&A) expenses were $34.1 million for the first quarter of 2020, compared to $11.7 million for the same period in 2019. The increase of $22.4 million is due to an increase of $15.6 million for selling related costs and an increase of $6.8 million for general and administrative costs. The increase in selling related costs is due primarily to hiring a sales force, resulting in an increase in labor expenses of approximately $9.9 million and commercialization costs of $5.8 million. The increase in general and administrative costs is due primarily to an increase in professional fees of approximately $2.1 million, labor related expenses of $1.5 million, and information technology expenses of $1.5 million.

    Cash, cash equivalents, restricted cash and investment securities totaled $450.4 million at March 31, 2020, compared to $224.0 million at December 31, 2019. In January 2020, the Company completed a $295.0 million public offering resulting in net proceeds to the Company of approximately $277.0 million from the sale of 10 million shares of its common stock, after deducting underwriting discounts and commissions and offering expenses paid by the Company.   

    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 9278748. Please dial in approximately 10 minutes prior to the call.

    CAPLYTA™ (lumateperone) is indicated for the treatment of schizophrenia in adults. CAPLYTA is available in 42 mg capsules.

    Important Safety Information

    Boxed Warning: Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. CAPLYTA is not approved for the treatment of patients with dementia-related psychosis.

    Contraindications: CAPLYTA is contraindicated in patients with known hypersensitivity to lumateperone or any components of CAPLYTA. Reactions have included pruritus, rash (e.g. allergic dermatitis, papular rash, and generalized rash), and urticaria.

    Warnings & Precautions: Antipsychotic drugs have been reported to cause:

    • Cerebrovascular Adverse Reactions in Elderly Patients with Dementia-Related Psychosis, including stroke and transient ischemic attack. See Boxed Warning above.
    • Neuroleptic Malignant Syndrome (NMS), which is a potentially fatal reaction. Signs and symptoms include: high fever, stiff muscles, confusion, changes in breathing, heart rate, and blood pressure, elevated creatinine phosphokinase, myoglobinuria (and/or rhabdomyolysis), and acute renal failure. Patients who experience signs and symptoms of NMS should immediately contact their doctor or go to the emergency room. 
    • Tardive Dyskinesia, a syndrome of uncontrolled body movements in the face, tongue, or other body parts, which may increase with duration of treatment and total cumulative dose. TD may not go away, even if CAPLYTA is discontinued. It can also occur after CAPLYTA is discontinued.
    • Metabolic Changes, including hyperglycemia, diabetes mellitus, dyslipidemia, and weight gain. Hyperglycemia, in some cases extreme and associated with ketoacidosis, hyperosmolar coma or death, has been reported in patients treated with antipsychotics. Measure weight and assess fasting plasma glucose and lipids when initiating CAPLYTA and monitor periodically during long-term treatment.
    • Leukopenia, Neutropenia, and Agranulocytosis (including fatal cases). Complete blood counts should be performed in patients with pre-existing low white blood cell count (WBC) or history of leukopenia or neutropenia. CAPLYTA should be discontinued if clinically significant decline in WBC occurs in absence of other causative factors.
    • Decreased Blood Pressure & Dizziness. Patients may feel lightheaded, dizzy or faint when they rise too quickly from a sitting or lying position (orthostatic hypotension). Heart rate and blood pressure should be monitored and patients should be warned with known cardiovascular or cerebrovascular disease. Orthostatic vital signs should be monitored in patients who are vulnerable to hypotension.
    • Falls. CAPLYTA may cause sleepiness or dizziness and can slow thinking and motor skills, which may lead to falls and, consequently, fractures and other injuries. Patients should be assessed for risk when using CAPLYTA.
    • Seizures. CAPLYTA should be used cautiously in patients with a history of seizures or with conditions that lower seizure threshold.
    • Sleepiness and Trouble Concentrating. Patients should use caution when operating machinery or motor vehicles until they know how CAPLYTA affects them.
    • Body Temperature Dysregulation. CAPLYTA should be used with caution in patients who may experience conditions that may increase core body temperature such as strenuous exercise, extreme heat, dehydration, or concomitant anticholinergics.
    • Dysphagia. CAPLYTA should be used with caution in patients at risk for aspiration.

    Drug Interactions: CAPLYTA should not be used with CYP3A4 inducers, moderate or strong CYP3A4 inhibitors and UGT inhibitors.

    Special Populations: Newborn infants exposed to antipsychotic drugs during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery. Breastfeeding is not recommended. Use of CAPLYTA should be avoided in patients with moderate or severe liver problems.

    Adverse Reactions: The most common adverse reactions in clinical trials with CAPLYTA vs. placebo were somnolence/sedation (24% vs. 10%) and dry mouth (6% vs. 2%).

    Please click here to see full Prescribing Information including Boxed Warning.

    About CAPLYTA (lumateperone)

    CAPLYTA is an oral, once daily medicine approved for the treatment of schizophrenia of adults (42mg/day). The mechanism of action of CAPLYTA in the treatment of schizophrenia is unknown. However, the efficacy of CAPLYTA could be mediated through a combination of antagonist activity at central serotonin 5-HT2A receptors and postsynaptic antagonist activity at central dopamine D2 receptors.

    CAPLYTA is being developed for the treatment of bipolar depression, depression and other neuropsychiatric and neurological disorders. CAPLYTA has not been demonstrated to be safe and effective in these other areas.

    About Intra-Cellular Therapies

    Intra-Cellular Therapies is a biopharmaceutical company founded on Nobel prize-winning research that allows us to understand how therapies affect the inner-workings of cells in the body. The company leverages this intracellular approach to develop innovative treatments for people living with complex psychiatric and neurologic diseases. For more information, please visit www.intracellulartherapies.com.

    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 expectations regarding the commercialization of CAPLYTA; the potential impact of the COVID-19 pandemic on the commercialization of CAPLYTA, manufacturing and supply of CAPLYTA and our product candidates, our ongoing and planned clinical trials and development programs, and any other aspects of our business; our goal to provide healthcare providers comprehensive education on CAPLYTA; our plans and the expected timing for the availability and reporting of data from our ongoing Phase 3 trials in bipolar depression; our development plans for our PDE program, including ITI-214 and our expected timing for the availability and reporting of data from our heart failure trial; our beliefs about the potential utility of our product candidates; 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: there are no guarantees that CAPLYTA will be commercially successful; we may encounter issues, delays or other challenges in commercializing CAPLYTA; the COVID-19 pandemic may negatively impact our commercial plans and sales for CAPLYTA; the COVID-19 pandemic may negatively impact the conduct of, and the timing of enrollment, completion and reporting with respect to, our clinical trials; whether CAPLYTA receives adequate reimbursement from third-party payors; the degree to which CAPLYTA receives acceptance from patients and physicians for its approved indication; challenges associated with execution of our sales activities, which in each case could limit the potential of our product; results achieved in CAPLYTA in the treatment of schizophrenia following commercial launch of the product may be different than observed in clinical trials, and may vary among patients; any other impacts on our business as a result of or related to the COVID-19 pandemic; risks associated with our current and planned clinical trials; we may encounter unexpected safety or tolerability issues with CAPLYTA following commercial launch for the treatment of schizophrenia or in ongoing or future trials and other development activities; 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 or in clinical trials for other indications; 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

    212-213-0006

    MEDIA INQUIRIES:

    Ana Fullmer
    Corporate Media Relations W2Owcg

    202-507-0130


    INTRA-CELLULAR THERAPIES, INC.
    CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
    (Unaudited)

      Three Months Ended March 31,
      2020   2019
    Revenues              
    Product sales, net $ 882,516     $  
    Grant revenue   200,963        
    Total revenues   1,083,479        
                   
    Operating expenses:              
    Cost of product sales   69,311        
    Research and development   16,003,326       24,990,856  
    Selling, general and administrative   34,096,366       11,704,984  
    Total operating expenses   50,169,003       36,695,840  
    Loss from operations   (49,085,524 )     (36,695,840 )
    Interest income   1,678,203       1,860,077  
    Loss before provision for income taxes   (47,407,321 )     (34,835,763 )
    Income tax expense   3,281        
    Net loss $ (47,410,602 )   $ (34,835,763 )
    Net loss per common share:              
    Basic & Diluted $ (0.73 )   $ (0.63 )
    Weighted average number of common shares:              
    Basic & Diluted   65,106,103       55,113,226  


    (1) The condensed consolidated statements of operations for the quarters ended March 31, 2020 and 2019 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

      March 31,
    2020

      December 31,
    2019
      (Unaudited)
       
    Assets      
    Current assets:      
    Cash and cash equivalents $ 179,593,032     $ 107,636,849  
    Investment securities, available-for-sale   269,360,926       116,373,335  
    Restricted cash   1,400,000        
    Accounts receivable, net   1,351,013        
    Inventory   1,391,124        
    Prepaid expenses and other current assets   7,876,405       6,313,785  
    Total current assets   460,972,500       230,323,969  
    Property and equipment, net   2,132,987       2,259,740  
    Right of use assets, net   18,051,146       18,252,074  
    Deferred tax asset, net         264,609  
    Other assets   86,084       86,084  
    Total assets $ 481,242,717     $ 251,186,476  
    Liabilities and stockholders' equity    
    Current liabilities:    
    Accounts payable $ 10,994,082     $ 7,425,024  
    Accrued and other current liabilities   10,667,765       16,138,909  
    Lease liabilities, short-term   3,211,234       3,187,435  
    Accrued employee benefits   6,203,283       9,472,651  
    Total current liabilities   31,076,364       36,224,019  
    Lease liabilities   19,718,023       19,955,186  
    Total liabilities   50,794,387       56,179,205  
    Stockholders' equity:    
    Common stock, $0.0001 par value: 100,000,000 shares authorized; 66,200,761 and 55,507,497 shares issued and outstanding at March 31, 2020 and December 31, 2019, respectively   6,620       5,551  
    Additional paid-in capital   1,188,095,880       904,971,772  
    Accumulated deficit   (757,508,971 )     (710,098,369 )
    Accumulated comprehensive (loss) gain   (145,199 )     128,317  
    Total stockholders' equity   430,448,330       195,007,271  
    Total liabilities and stockholders' equity $ 481,242,717     $ 251,186,476  


    (1) The condensed consolidated balance sheets at March 31, 2020 and December 31, 2019 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.

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  25. NEW YORK, April 29, 2020 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (NASDAQ:ITCI), a biopharmaceutical company focused on the development of and commercialization of therapeutics for central nervous system (CNS) disorders, today announced that it will host a conference call and live webcast discussion at 8:30 a.m. Eastern Time on Thursday, May 7, 2020, to provide a corporate update and discuss details of the Company's financial results for the quarter ended March 31, 2020.

    To access the live conference call via phone, dial 1-(844) 835-6563. The international dial-in number is 1-(970) 315-3916. The conference ID number for the live call is 9278748.

    The live and archived webcast can be accessed under "Press Releases & Events" in the…

    NEW YORK, April 29, 2020 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (NASDAQ:ITCI), a biopharmaceutical company focused on the development of and commercialization of therapeutics for central nervous system (CNS) disorders, today announced that it will host a conference call and live webcast discussion at 8:30 a.m. Eastern Time on Thursday, May 7, 2020, to provide a corporate update and discuss details of the Company's financial results for the quarter ended March 31, 2020.

    To access the live conference call via phone, dial 1-(844) 835-6563. The international dial-in number is 1-(970) 315-3916. The conference ID number for the live call is 9278748.

    The live and archived webcast can be accessed under "Press Releases & Events" in the Investor Relations section of the Company's website at www.intracellulartherapies.com. Please log in approximately 5-10 minutes prior to the event to register and to download and install any necessary software.

    About Intra-Cellular Therapies

    Intra-Cellular Therapies is a biopharmaceutical company founded on Nobel prize-winning research that allows us to understand how therapies affect the inner-workings of cells in the body. The company leverages this intracellular approach to develop innovative treatments for people living with complex psychiatric and neurologic diseases. For more information, please visit www.intracellulartherapies.com.

    Contact:

    Intra-Cellular Therapies, Inc.
    Juan Sanchez, M.D. 
    Vice President, Corporate Communications and Investor Relations
    646-440-9333

    Burns McClellan, Inc.
    Lisa Burns

    212-213-0006

    MEDIA INQUIRIES:

    Ana Fullmer
    Corporate Media Relations W2Owcg

    202-507-0130

    Primary Logo

    View Full Article Hide Full Article
  26. NEW YORK, April 16, 2020 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (NASDAQ:ITCI), a biopharmaceutical company focused on the development and commercialization of therapeutics for central nervous system (CNS) disorders, today announced the grant to 266 new employees of inducement stock options to purchase an aggregate of 33,040 shares of its common stock and restricted stock units for an aggregate of 267,729 shares of its common stock under its 2019 Inducement Award Plan. The stock options are exercisable at a price of $15.81 per share, the closing price of Intra-Cellular Therapies' common stock on March 30, 2020, the grant date. The stock options and restricted stock units were granted as inducements material to each employee's acceptance…

    NEW YORK, April 16, 2020 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (NASDAQ:ITCI), a biopharmaceutical company focused on the development and commercialization of therapeutics for central nervous system (CNS) disorders, today announced the grant to 266 new employees of inducement stock options to purchase an aggregate of 33,040 shares of its common stock and restricted stock units for an aggregate of 267,729 shares of its common stock under its 2019 Inducement Award Plan. The stock options are exercisable at a price of $15.81 per share, the closing price of Intra-Cellular Therapies' common stock on March 30, 2020, the grant date. The stock options and restricted stock units were granted as inducements material to each employee's acceptance of employment with Intra-Cellular Therapies in accordance with Nasdaq Listing Rule 5635(c)(4).

    Each stock option has a 10-year term. Each stock option and restricted stock unit vests in a series of three equal annual installments on each anniversary of the grant date over a three-year period, subject to the employee's continued service with Intra-Cellular Therapies through the applicable vesting dates. The stock options and restricted stock units are subject to the terms and conditions of Intra-Cellular Therapies' 2019 Inducement Award Plan, and the terms and conditions of equity award agreements covering the grants.

    About Intra-Cellular Therapies

    Intra-Cellular Therapies is a biopharmaceutical company founded on Nobel prize-winning research that allows it to understand how therapies affect the inner-workings of cells in the body. The Company leverages this intracellular approach to develop innovative treatments for people living with complex psychiatric and neurologic diseases. For more information, please visit www.intracellulartherapies.com.

    Contact

    Intra-Cellular Therapies, Inc.
    Juan Sanchez, M.D.
    Vice President, Corporate Communications and Investor Relations
    646-440-9333

    Burns McClellan, Inc.
    Lisa Burns

    212-213-0006

    MEDIA INQUIRIES:

    Ana Fullmer
    Corporate Media Relations W2Owcg

    202-507-0130

    Primary Logo

    View Full Article Hide Full Article
  27. NEW YORK, April 02, 2020 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (NASDAQ:ITCI), a biopharmaceutical company focused on the development and commercialization of therapeutics for central nervous system (CNS) disorders, today announced it has successfully initiated its promotional activities associated with the launch of CAPLYTA (lumateperone). CAPLYTA is an oral, once daily medicine approved for the treatment of schizophrenia in adults.

    A national CAPLYTA launch meeting, which included the Company's full sales force and its entire commercial leadership team, was held during the week of March 23, 2020 using remote meeting technology in recognition of the current COVID-19 environment. The Company's sales organization is now actively…

    NEW YORK, April 02, 2020 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (NASDAQ:ITCI), a biopharmaceutical company focused on the development and commercialization of therapeutics for central nervous system (CNS) disorders, today announced it has successfully initiated its promotional activities associated with the launch of CAPLYTA (lumateperone). CAPLYTA is an oral, once daily medicine approved for the treatment of schizophrenia in adults.

    A national CAPLYTA launch meeting, which included the Company's full sales force and its entire commercial leadership team, was held during the week of March 23, 2020 using remote meeting technology in recognition of the current COVID-19 environment. The Company's sales organization is now actively engaging healthcare providers with the goal of providing comprehensive education on CAPLYTA. The sales force is fully equipped with remote product presentation and sampling capability.  These activities are complemented by expanded digital outreach programs.  

    "I am proud of our successful execution of a full virtual launch and the array of activities we have developed to support the launch of CAPLYTA," said Dr. Sharon Mates, Chairman and CEO of Intra-Cellular Therapies. "In addition, patient access and affordability continue to be a high priority for us as we bring CAPLYTA to the market. I am pleased to announce the introduction of the LYTAlink program which is now available to provide a number of access and affordability offerings to eligible CAPLYTA patients and their healthcare providers."

    The LYTAlink program offerings consist of coverage and reimbursement services, out-of-pocket copay support for commercially insured patients, medication compliance communications, and patient assistance relief specifically for those without insurance. LYTAlink is designed to be the link between CAPLYTA and the eligible schizophrenia patients who may benefit from this program. 

    Mental health community services and resources are extremely important as the country addresses the impact of the COVID-19 crisis. The efforts of the mental health advocacy community in bringing important educational resources and raising emerging policy concerns into the national, state, and local response is to be commended.

    CAPLYTA™ (lumateperone) is indicated for the treatment of schizophrenia in adults. CAPLYTA is available in 42 mg capsules.

    Important Safety Information

    Boxed Warning: Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. CAPLYTA is not approved for the treatment of patients with dementia-related psychosis.

    Contraindications: CAPLYTA is contraindicated in patients with known hypersensitivity to lumateperone or any components of CAPLYTA. Reactions have included pruritus, rash (e.g. allergic dermatitis, papular rash, and generalized rash), and urticaria.

    Warnings & Precautions: Antipsychotic drugs have been reported to cause:

    • Cerebrovascular Adverse Reactions in Elderly Patients with Dementia-Related Psychosis, including stroke and transient ischemic attack. See Boxed Warning above.
    • Neuroleptic Malignant Syndrome (NMS), which is a potentially fatal reaction. Signs and symptoms include: high fever, stiff muscles, confusion, changes in breathing, heart rate, and blood pressure, elevated creatinine phosphokinase, myoglobinuria (and/or rhabdomyolysis), and acute renal failure. Patients who experience signs and symptoms of NMS should immediately contact their doctor or go to the emergency room. 
    • Tardive Dyskinesia, a syndrome of uncontrolled body movements in the face, tongue, or other body parts, which may increase with duration of treatment and total cumulative dose. TD may not go away, even if CAPLYTA is discontinued. It can also occur after CAPLYTA is discontinued.
    • Metabolic Changes, including hyperglycemia, diabetes mellitus, dyslipidemia, and weight gain. Hyperglycemia, in some cases extreme and associated with ketoacidosis, hyperosmolar coma or death, has been reported in patients treated with antipsychotics. Measure weight and assess fasting plasma glucose and lipids when initiating CAPLYTA and monitor periodically during long-term treatment.
    • Leukopenia, Neutropenia, and Agranulocytosis (including fatal cases). Complete blood counts should be performed in patients with pre-existing low white blood cell count (WBC) or history of leukopenia or neutropenia. CAPLYTA should be discontinued if clinically significant decline in WBC occurs in absence of other causative factors.
    • Decreased Blood Pressure & Dizziness. Patients may feel lightheaded, dizzy or faint when they rise too quickly from a sitting or lying position (orthostatic hypotension). Heart rate and blood pressure should be monitored and patients should be warned with known cardiovascular or cerebrovascular disease. Orthostatic vital signs should be monitored in patients who are vulnerable to hypotension.
    • Falls. CAPLYTA may cause sleepiness or dizziness and can slow thinking and motor skills, which may lead to falls and, consequently, fractures and other injuries. Patients should be assessed for risk when using CAPLYTA.
    • Seizures. CAPLYTA should be used cautiously in patients with a history of seizures or with conditions that lower seizure threshold.
    • Sleepiness and Trouble Concentrating. Patients should use caution when operating machinery or motor vehicles until they know how CAPLYTA affects them.
    • Body Temperature Dysregulation. CAPLYTA should be used with caution in patients who may experience conditions that may increase core body temperature such as strenuous exercise, extreme heat, dehydration, or concomitant anticholinergics.
    • Dysphagia. CAPLYTA should be used with caution in patients at risk for aspiration.

    Drug Interactions: CAPLYTA should not be used with CYP3A4 inducers, moderate or strong CYP3A4 inhibitors and UGT inhibitors.

    Special Populations: Newborn infants exposed to antipsychotic drugs during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery. Breastfeeding is not recommended. Use of CAPLYTA should be avoided in patients with moderate or severe liver problems.

    Adverse Reactions: The most common adverse reactions in clinical trials with CAPLYTA vs. placebo were somnolence/sedation (24% vs. 10%) and dry mouth (6% vs. 2%).

    Please click here to see full Prescribing Information including Boxed Warning.

    About CAPLYTA (lumateperone)

    CAPLYTA is an oral, once daily medicine approved for the treatment of schizophrenia of adults (42mg/day).

    The mechanism of action of CAPLYTA in the treatment of schizophrenia is unknown. However, the efficacy of CAPLYTA could be mediated through a combination of antagonist activity at central serotonin 5-HT2A receptors and postsynaptic antagonist activity at central dopamine D2 receptors.

    CAPLYTA is being developed for the treatment of bipolar depression, behavioral disturbances in patients with dementia, including Alzheimer's disease, depression and other neuropsychiatric and neurological disorders. CAPLYTA has not been demonstrated to be safe and effective in these other areas.

    About Intra-Cellular Therapies

    Intra-Cellular Therapies is a biopharmaceutical company founded on Nobel prize-winning research that allows us to understand how therapies affect the inner-workings of cells in the body. The company leverages this intracellular approach to develop innovative treatments for people living with complex psychiatric and neurologic diseases. For more information, please visit www.intracellulartherapies.com.

    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 expectations regarding our commercialization of CAPLYTA, including the impact of COVID-19 on the commercialization of CAPLYTA and the promotional efforts we expect to utilize in support of the product; our goal to provide healthcare providers with comprehensive education on CAPLYTA; the ability for LYTAlink to be the link between CAPLYTA and the eligible schizophrenia patients who may benefit from this program; and our beliefs about the potential utility of our product candidates; 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: there are no guarantees that CAPLYTA will be commercially successful; we may encounter issues, delays or other challenges in launching or commercializing CAPLYTA; the COVID-19 pandemic may negatively impact our commercial plans and sales for CAPLYTA; the COVID-19 pandemic may negatively impact the conduct of, and the timing of enrollment, completion and reporting with respect to, our clinical trials,  whether CAPLYTA receives adequate reimbursement from third-party payors; the degree to which CAPLYTA receives acceptance from patients and physicians for its approved indication; challenges associated with execution of our sales activities, which in each case could limit the potential of our product; results achieved in CAPLYTA in the treatment of schizophrenia once we have launched the product may be different than observed in clinical trials, and may vary among patients; any other impacts on our business as a result of or related to the COVID-19 pandemic; risks associated with our current and planned clinical trials; we may encounter unexpected safety or tolerability issues with CAPLYTA for the treatment of schizophrenia or in ongoing or future trials and other development activities; 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 U.S. Food and Drug Administration; 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

    212-213-0006

    MEDIA INQUIRIES:

    Ana Fullmer
    Corporate Media Relations W2Owcg

    202-507-0130

    Primary Logo

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  28. NEW YORK, March 02, 2020 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (NASDAQ:ITCI), a biopharmaceutical company focused on the development and commercialization of therapeutics for central nervous system (CNS) disorders, today announced its financial results for the fourth quarter and year ending December 31, 2019, and provided a corporate update.

    "We are very excited about the recent FDA approval of CAPLYTA™ (lumateperone) for the treatment of schizophrenia and we are fully prepared for our planned commercial launch later this month," said Dr. Sharon Mates, Chairman and CEO of Intra-Cellular Therapies. "We have also continued to advance our pipeline programs in 2019 and anticipate a number of meaningful developments in 2020, including…

    NEW YORK, March 02, 2020 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (NASDAQ:ITCI), a biopharmaceutical company focused on the development and commercialization of therapeutics for central nervous system (CNS) disorders, today announced its financial results for the fourth quarter and year ending December 31, 2019, and provided a corporate update.

    "We are very excited about the recent FDA approval of CAPLYTA™ (lumateperone) for the treatment of schizophrenia and we are fully prepared for our planned commercial launch later this month," said Dr. Sharon Mates, Chairman and CEO of Intra-Cellular Therapies. "We have also continued to advance our pipeline programs in 2019 and anticipate a number of meaningful developments in 2020, including reporting topline data from our lumateperone Phase 3 trial in bipolar depression and topline data from our ITI-214 Phase 1/2 trial in heart failure."

    CORPORATE UPDATE

    CAPLYTA

    Schizophrenia

    • In December 2019, we announced that the U.S. Food and Drug Administration (FDA) had approved CAPLYTA for the treatment of schizophrenia in adults. Our preparations for the commercial launch of CAPLYTA later this month are fully on track.  
       
    • In support of our commercialization efforts, we expect to deploy a national sales force consisting of approximately 240 sales representatives.  Our sales leadership team and the substantial majority of our sales representatives are on board and training activities are ongoing.  Our market access team is actively engaged in product discussions with payors.  Manufacturing and supply chain related activities are in place to support commercial supply. At the time of launch, CAPLYTA will be priced in line with other currently marketed branded antipsychotics indicated for the treatment of schizophrenia.
       
    • The efficacy of CAPLYTA 42 mg was demonstrated in two placebo-controlled trials, showing a statistically significant benefit over placebo on the primary endpoint, the Positive and Negative Syndrome Scale (PANSS) total score. The most common adverse reactions (≥5% and twice the rate of placebo) for the recommended dose of CAPLYTA vs. placebo were somnolence/sedation (24% vs.10%) and dry mouth (6% vs. 2%). In pooled data from short term studies, mean changes from baseline in weight gain, fasting glucose, triglycerides and total cholesterol were similar between CAPLYTA and placebo. The incidence of extrapyramidal symptoms was 6.7% for CAPLYTA and 6.3% for placebo.

    • At the 2019 American College of Neuropsychopharmacology (ACNP) annual meeting, we made presentations highlighting results from CAPLYTA short-term placebo controlled studies and the long-term safety study. We recently announced the publication of results from the CAPLYTA clinical trial (ITI-007-301) in adult patients with schizophrenia. The article, "Efficacy and Safety of Lumateperone for Treatment of Schizophrenia: A Randomized Clinical Trial" (Correll et al. 2020), is available online in JAMA Psychiatry.

    Lumateperone Programs

    Bipolar Depression

    • In July 2019, we announced positive topline results from Study 404, a Phase 3 trial of lumateperone in patients with a major depressive episode associated with either Bipolar I or Bipolar II disorder. Lumateperone met its primary endpoint of superior improvement from baseline at Week 6 on the Montgomery-Åsberg Depression Rating Scale (MADRS) total score versus placebo (p<0.0001; effect size = 0.56). These benefits were statistically significant in both Bipolar I and Bipolar II patients. In a second Phase 3 trial, Study 401, lumateperone did not separate from placebo; the placebo response was high in this trial. The results from Study 404 were presented at ACNP in December 2019. 
       
    • Our global adjunctive bipolar depression Phase 3 trial, Study 402, is ongoing.  We anticipate reporting topline results from this trial in mid-2020. We have commenced  an additional Phase 3 study, Study 403, evaluating lumateperone as monotherapy in the treatment of major depressive episodes associated with Bipolar I or Bipolar II disorder.  Subject to the results of Study 402 and our interactions with the FDA regarding our bipolar depression program, in late 2020 we expect to submit a supplemental new drug application (sNDA) to the FDA for regulatory approval for lumateperone for the treatment of bipolar depression.

    Long-Acting Injectable (LAI) Formulation

    • Within the lumateperone portfolio, we are also developing a long-acting injectable formulation to provide more treatment options to patients suffering from schizophrenia. We have completed the preclinical development of an LAI formulation and plan to initiate a Phase 1 clinical trial in 2020.

    Major Depressive Disorder (MDD)

    • We have commenced our program of lumateperone in MDD.  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 and other novel compounds. Pharmacokinetic studies evaluating these novel formulations are currently ongoing.  We anticipate initiating a Phase 2 clinical trial in major depressive disorder in 2020.             

    Other Programs

    ITI-214 Program

    • We intend to pursue the development of our phosphodiesterase program for the treatment of several CNS and non-CNS conditions with a focus on diseases where excessive PDE1 activity has been demonstrated and/or increased inflammation is an important contributor to disease pathogenesis.

    • Our Phase 1/2 clinical trial of escalating single doses of ITI-214, our phosphodiesterase 1 (PDE1) inhibitor, evaluating hemodynamic effects and safety in patients with systolic heart failure, is nearing completion.  Assessment of vital signs, left ventricular contractility and power using echocardiography (ECG), and ectopic arrythmias using continuous ECG monitoring are being made following the administration of ITI-214. The trial evaluates three dose cohorts 10 mg, 30 mg and 90 mg, and no safety concerns have been identified to date. We anticipate reporting topline results from this trial in the first half of 2020.

    ITI-333 Program

    • We plan to develop ITI-333, our novel, oral modulator of mu opioid and serotonin receptors, for the treatment of opioid and other substance use disorders, pain, and mood disorders. The pharmacological profile has the potential to translate into clinical utility as a therapeutic to ease opioid withdrawal symptoms and drug craving associated with opioid use disorder as well for analgesia with minimal addictive potential. This pharmacological profile was presented at ACNP in December 2019. We expect to initiate our clinical program in 2020.

    Selected Fourth Quarter and Year End 2019 Financial Results

    Intra-Cellular Therapies (the Company or ITCI) reported a net loss of $40.6 million, or $0.74 per share (basic and diluted), for the fourth quarter of 2019 compared to a net loss of $40.7 million, or $0.75 per share (basic and diluted), for the fourth quarter of 2018. The Company reported a net loss of $147.7 million, or $2.68 per share (basic and diluted), for the full year ended December 31, 2019 compared with a net loss of $155.1 million, or $2.84 per share (basic and diluted), for the full year ended December 31, 2018.

    Research and development (R&D) expenses for the fourth quarter of 2019 were $19.1 million, compared to $33.6 million for the fourth quarter of 2018.  The $14.5 million decrease is primarily due to lower clinical and non-clinical related costs for lumateperone, and is partially offset by higher manufacturing costs, non ITI-007 related projects and labor costs in the fourth quarter of 2019. Research and development expenses for the year ended December 31, 2019 were $89.1 million, compared to $132.2 million for the year ended December 31, 2018. The $43.1 million decrease is due primarily to lower clinical trial costs and to a lesser extent manufacturing costs for lumateperone, and is partially offset by higher non ITI-007 related projects and labor costs.

    General and administrative (G&A) expenses were $22.8 million for the fourth quarter of 2019, compared to $9.0 million for the same period in 2018. The increase of $13.8 million is due primarily to an increase in precommercialization costs, and to a lesser extent labor costs and stock compensation expense. General and administrative expenses for the year ended December 31, 2019 were $64.9 million, compared to $30.1 million for the year ended December 31, 2018. The increase of $34.8 million is primarily due to increases in precommercialization costs, labor costs, stock compensation expense and facilities related costs. 

    Cash, cash equivalents and investment securities totaled $224.0 million at December 31, 2019, compared to $347.5 million at December 31, 2018. In January 2020, the Company completed a $295.0 million follow on public offering resulting in net proceeds to the Company of approximately $276.9 million from the sale of 10 million shares of its common stock, after deducting underwriting discounts and commissions and estimated offering expenses payable by the Company.   

    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 4676624. Please dial in approximately 10 minutes prior to the call.

    Important Safety Information

    Boxed Warning: Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. CAPLYTA is not approved for the treatment of patients with dementia-related psychosis.

    Contraindications: CAPLYTA is contraindicated in patients with known hypersensitivity to lumateperone or any components of CAPLYTA.

    Warnings & Precautions: Antipsychotic drugs have been reported to cause:

    • Cerebrovascular Adverse Reactions in Elderly Patients with Dementia-Related Psychosis, including stroke and transient ischemic attack.  See BOXED WARNING above.
       
    • Neuroleptic Malignant Syndrome, which is a potentially fatal reaction. Signs and symptoms include: hyperpyrexia, muscle rigidity, delirium, autonomic instability, elevated creatinine phosphokinase, myoglobinuria (and/or rhabdomyolysis), and acute renal failure. Manage with immediate discontinuation of CAPLYTA and close monitoring.
       
    • Tardive Dyskinesia, a syndrome of potentially irreversible, dyskinetic, and involuntary movements which may increase as the duration of treatment and total cumulative dose increases. Discontinue CAPLYTA if clinically appropriate.
       
    • Metabolic Changes, including hyperglycemia, diabetes mellitus, dyslipidemia, and weight gain. Measure weight and assess fasting plasma glucose and lipids when initiating CAPLYTA and monitor periodically during long-term treatment.
       
    • Leukopenia, Neutropenia, and Agranulocytosis (including fatal cases). Perform complete blood counts in patients with pre-existing low white blood cell count (WBC) or history of leukopenia or neutropenia. Discontinue CAPLYTA if clinically significant decline in WBC occurs in absence of other causative factors.
       
    • Orthostatic Hypotension and Syncope. Monitor heart rate and blood pressure and warn patients with known cardiovascular or cerebrovascular disease.
       
    • Falls. CAPLYTA may cause somnolence, postural hypotension, and motor and/or sensory instability, which may lead to falls and, consequently, fractures and other injuries. Assess patients for risk when using CAPLYTA.
       
    • Seizures. Use CAPLYTA cautiously in patients with a history of seizures or with conditions that lower seizure threshold.
       
    • Potential for Cognitive and Motor Impairment. Advise patients to use caution when operating machinery or motor vehicles until they are reasonably certain CAPLYTA therapy does not affect them adversely. 
       
    • Body Temperature Dysregulation. Use CAPLYTA with caution in patients who may experience conditions that may increase core body temperature such as strenuous exercise, extreme heat, dehydration, or concomitant anticholinergics.
       
    • Dysphagia. Use CAPLYTA with caution in patients at risk for aspiration.

    Drug Interactions: Avoid concomitant use with CYP3A4 inducers and moderate or strong CYP3A4 inhibitors.

    Special Populations: Neonates exposed to antipsychotic drugs during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery. Breastfeeding is not recommended.  Avoid use in patients with moderate or severe hepatic impairment.

    Adverse Reactions: The most common adverse reactions in clinical trials with CAPLYTA vs. placebo were somnolence/sedation (24% vs. 10%) and dry mouth (6% vs. 2%).

    Please click here to see full Prescribing Information including Boxed Warning.

    About CAPLYTA (lumateperone)

    CAPLYTA is an oral, once daily medicine approved for the treatment of schizophrenia of adults (42mg/day).

    The mechanism of action of CAPLYTA in the treatment of schizophrenia is unknown. However, the efficacy of CAPLYTA could be mediated through a combination of antagonist activity at central serotonin 5-HT2A receptors and postsynaptic antagonist activity at central dopamine D2 receptors.

    CAPLYTA is being developed for the treatment of bipolar depression, behavioral disturbances in patients with dementia, including Alzheimer's disease, depression and other neuropsychiatric and neurological disorders. CAPLYTA has not been demonstrated to be safe and effective in these other areas.

    About Intra-Cellular Therapies

    Intra-Cellular Therapies is a biopharmaceutical company founded on Nobel prize-winning research that allows us to understand how therapies affect the inner-workings of cells in the body. The company leverages this intracellular approach to develop innovative treatments for people living with complex psychiatric and neurologic diseases. For more information, please visit www.intracellulartherapies.com.

    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 expectations regarding the timing of our commercial launch of CAPLYTA, the sales force that we expect to deploy in support of the product and the expected pricing of CAPLYTA; our plans and the expected timing for the availability and reporting of data from our ongoing Phase 3 trials in bipolar depression, and our expectations about the timing of our sNDA submission for bipolar depression; our expectations about the timing of the initiation of a clinical study in connection with our long acting injectable formulation of lumateperone; our expected timing of the initiation of a clinical trial of lumateperone in MDD; our development plans for our PDE program, including ITI-214 and our expected timing reporting topline results for our heart failure trial; our development plans for our ITI-333 program and our expected timing of the initiation of clinical trials for ITI-333; our beliefs about the potential utility of our product candidates; 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: there are no guarantees that CAPLYTA will be commercially successful; we may encounter issues, delays or other challenges in launching or commercializing CAPLYTA; whether CAPLYTA receives adequate reimbursement from third-party payors; the degree to which CAPLYTA receives acceptance from patients and physicians for its approved indication; challenges associated with execution of our sales activities, which in each case could limit the potential of our product; results achieved in CAPLYTA in the treatment of schizophrenia once we have launched the product may be different than observed in clinical trials, and may vary among patients; risks associated with our current and planned clinical trials; we may encounter unexpected safety or tolerability issues with CAPLYTA following commercial launch for the treatment of schizophrenia or in ongoing or future trials and other development activities; 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

    212-213-0006

    MEDIA INQUIRIES:

    Ana Fullmer
    Corporate Media Relations W2Owcg

    202-507-0130


    INTRA-CELLULAR THERAPIES, INC.
    CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

             
      Three Months Ended December 31, Year Ended December 31,
      2019   2018   2019(1)   2018(1)
             
      (Unaudited) (Unaudited) (Unaudited) (Audited)
             
    Revenues $   60,613     $     $   60,613     $  
             
    Costs and expenses:        
    Research and development     19,065,725       33,605,629         89,124,838       132,166,913  
    General and administrative     22,763,547       9,017,311         64,947,625       30,099,855  
    Total costs and expenses     41,829,272       42,622,940         154,072,463       162,266,768  
             
    Loss from operations     (41,768,659 )     (42,622,940 )       (154,011,850 )     (162,266,768 )
    Interest income     (1,185,808 )     (1,874,904 )       (6,291,272 )     (7,140,957 )
    Income tax expense                   1,600       1,600  
    Net loss $ (40,582,851 )   $ (40,748,036 )   $ (147,722,178 )   $ (155,127,411 )
             
    Net loss per common share:        
    Basic & Diluted $   (0.74 )   $ (0.75 )   $   (2.68 )   $ (2.84 )
             
    Weighted average number of common shares:        
    Basic & Diluted     55,276,251       54,750,566         55,186,206       54,707,865  

    (1)   The condensed consolidated statements of operations for the years ended December 31, 2019 and 2018 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

         
         
      December 31,
    2019 (1)

      December 31,
    2018 (1)
      (Unaudited)
      (Audited)
    Assets    
    Current assets:    
    Cash and cash equivalents $   107,636,849     $ 54,947,502  
    Investment securities, available-for-sale     116,373,335       292,583,046  
    Prepaid expenses and other current assets     6,313,785       7,908,133  
    Total current assets     230,323,969       355,438,681  
    Property and equipment, net     2,259,740       1,159,766  
    Right of use assets, net     18,252,074        
    Deferred tax asset, net     264,609       529,218  
    Other assets     86,084       78,833  
    Total assets $   251,186,476     $ 357,206,498  
         
    Liabilities and stockholders' equity    
    Current liabilities:    
    Accounts payable     7,425,024       13,961,060  
    Accrued and other current liabilities     16,138,909       20,044,866  
    Lease liabilities, short-term     3,187,435        
    Accrued employee benefits     9,472,651       2,293,259  
    Total current liabilities     36,224,019       36,299,185  
    Deferred rent             3,192,432  
    Lease liabilities   19,955,186        
    Total liabilities     56,179,205       39,491,617  
         
    Stockholders' equity:    
    Common stock, $0.0001 par value: 100,000,000 shares authorized; 55,507,497 and 54,895,295 shares issued and outstanding at December 31, 2019 and December 31, 2018, respectively     5,551       5,490  
    Additional paid-in capital     904,971,772       880,753,339  
    Accumulated deficit     (710,098,369 )     (562,376,191 )
    Accumulated comprehensive loss     128,317       (667,757 )
    Total stockholders' equity     195,007,271       317,714,881  
    Total liabilities and stockholders' equity $   251,186,476     $ 357,206,498  
         

    (1)   The condensed consolidated balance sheets at December 31, 2019 and 2018 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.

     

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  29. NEW YORK, Feb. 24, 2020 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (NASDAQ:ITCI), a biopharmaceutical company focused on the development of and commercialization of therapeutics for central nervous system (CNS) disorders, today announced that it will host a conference call and live webcast discussion at 8:30 a.m. Eastern Time on Monday, March 2, 2020, to provide a corporate update and discuss details of the Company's financial results for the quarter and year ended December 31, 2019.

    To access the live conference call via phone, dial 1-(844) 835-6563. The international dial-in number is 1-(970) 315-3916. The conference ID number for the live call is 4676624.

    The live and archived webcast can be accessed under "Press Releases & Events…

    NEW YORK, Feb. 24, 2020 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (NASDAQ:ITCI), a biopharmaceutical company focused on the development of and commercialization of therapeutics for central nervous system (CNS) disorders, today announced that it will host a conference call and live webcast discussion at 8:30 a.m. Eastern Time on Monday, March 2, 2020, to provide a corporate update and discuss details of the Company's financial results for the quarter and year ended December 31, 2019.

    To access the live conference call via phone, dial 1-(844) 835-6563. The international dial-in number is 1-(970) 315-3916. The conference ID number for the live call is 4676624.

    The live and archived webcast can be accessed under "Press Releases & Events" in the Investor Relations section of the Company's website at www.intracellulartherapies.com. Please log in approximately 5-10 minutes prior to the event to register and to download and install any necessary software.

    About Intra-Cellular Therapies

    Intra-Cellular Therapies is a biopharmaceutical company founded on Nobel prize-winning research that allows us to understand how therapies affect the inner-workings of cells in the body. The company leverages this intracellular approach to develop innovative treatments for people living with complex psychiatric and neurologic diseases. For more information, please visit www.intracellulartherapies.com.

    Contact:

    Intra-Cellular Therapies, Inc.
    Juan Sanchez, M.D. 
    Vice President, Corporate Communications and Investor Relations
    646-440-9333

    Burns McClellan, Inc.
    Lisa Burns

    212-213-0006

    MEDIA INQUIRIES:

    Ana Fullmer
    Corporate Media Relations W2Owcg

    202-507-0130

    Primary Logo

    View Full Article Hide Full Article
  30. NEW YORK, Feb. 21, 2020 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (NASDAQ:ITCI), a biopharmaceutical company focused on the development and commercialization of therapeutics for central nervous system (CNS) disorders, today announced the grant to four new employees of inducement stock options to purchase an aggregate of 6,688 shares of its common stock and restricted stock units for an aggregate of 6,681 shares of its common stock under its 2019 Inducement Award Plan. The stock options are exercisable at a price of $23.94 per share, the closing price of Intra-Cellular Therapies' common stock on February 18, 2020, the grant date. The stock options and restricted stock units were granted as inducements material to each employee's acceptance…

    NEW YORK, Feb. 21, 2020 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (NASDAQ:ITCI), a biopharmaceutical company focused on the development and commercialization of therapeutics for central nervous system (CNS) disorders, today announced the grant to four new employees of inducement stock options to purchase an aggregate of 6,688 shares of its common stock and restricted stock units for an aggregate of 6,681 shares of its common stock under its 2019 Inducement Award Plan. The stock options are exercisable at a price of $23.94 per share, the closing price of Intra-Cellular Therapies' common stock on February 18, 2020, the grant date. The stock options and restricted stock units were granted as inducements material to each employee's acceptance of employment with Intra-Cellular Therapies in accordance with Nasdaq Listing Rule 5635(c)(4).

    Each stock option has a 10-year term. Each stock option and restricted stock unit vests in a series of three equal annual installments on each anniversary of the grant date over a three-year period, subject to the employee's continued service with Intra-Cellular Therapies through the applicable vesting dates. The stock options and restricted stock units are subject to the terms and conditions of Intra-Cellular Therapies' 2019 Inducement Award Plan, and the terms and conditions of equity award agreements covering the grants.

    About Intra-Cellular Therapies
    Intra-Cellular Therapies is a biopharmaceutical company founded on Nobel prize-winning research that allows it to understand how therapies affect the inner-workings of cells in the body. The Company leverages this intracellular approach to develop innovative treatments for people living with complex psychiatric and neurologic diseases. For more information, please visit www.intracellulartherapies.com.

    Contact

    Intra-Cellular Therapies, Inc.
    Juan Sanchez, M.D.
    Vice President, Corporate Communications and Investor Relations
    646-440-9333

    Burns McClellan, Inc.
    Lisa Burns

    212-213-0006

    MEDIA INQUIRIES:

    Ana Fullmer
    Corporate Media Relations W2Owcg

    202-507-0130

    Primary Logo

    View Full Article Hide Full Article
  31. NEW YORK, Feb. 20, 2020 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (NASDAQ:ITCI), a biopharmaceutical company focused on the development and commercialization of therapeutics for central nervous system (CNS) disorders, announced the publication of results from its CAPLYTA (lumateperone) clinical trial (ITI-007-301) in adult patients with schizophrenia. The article, "Efficacy and Safety of Lumateperone for Treatment of Schizophrenia: A Randomized Clinical Trial" (Correll et al. 2020), was recently published online in JAMA Psychiatry and is available here.

    In this trial, CAPLYTA 42 mg met the primary endpoint and demonstrated antipsychotic efficacy with statistically significant superiority over placebo at Week 4 as measured by the change…

    NEW YORK, Feb. 20, 2020 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (NASDAQ:ITCI), a biopharmaceutical company focused on the development and commercialization of therapeutics for central nervous system (CNS) disorders, announced the publication of results from its CAPLYTA (lumateperone) clinical trial (ITI-007-301) in adult patients with schizophrenia. The article, "Efficacy and Safety of Lumateperone for Treatment of Schizophrenia: A Randomized Clinical Trial" (Correll et al. 2020), was recently published online in JAMA Psychiatry and is available here.

    In this trial, CAPLYTA 42 mg met the primary endpoint and demonstrated antipsychotic efficacy with statistically significant superiority over placebo at Week 4 as measured by the change from baseline on the Positive and Negative Syndrome Scale (PANSS) total score (drug-placebo difference = -4.2 points). CAPLYTA 42 mg also met the key secondary endpoint of statistically significant improvement on the Clinical Global Impression Scale for Severity of Illness. CAPLYTA 42 mg showed significant antipsychotic efficacy as early as week 1, which was maintained at every time point throughout the study.

    The most commonly reported adverse events occurring for CAPLYTA 42 mg in ≥5% of patients and >2 times the rate in the placebo group were somnolence (CAPLYTA 42 mg, 17.3% vs placebo, 4.0%), sedation (12.7% vs 5.4%), fatigue (5.3% vs 1.3%), and constipation (6.7% vs 2.7%).

    No significant differences were observed compared to placebo on metabolic parameters, including weight, cholesterol, triglycerides, glucose and insulin, or on prolactin levels. No extrapyramidal symptoms (EPS)–related TEAEs occurred in 5% or more of patients in any treatment arm.

    "Treatment with CAPLYTA 42 mg significantly improved symptoms in patients with acute exacerbation of schizophrenia with a favorable tolerability profile," said Dr. Christoph Correll, Professor of Psychiatry and Molecular Medicine at the Zucker School of Medicine at Hofstra/Northwell, New York. "CAPLYTA represents an important addition to the treatment options of healthcare providers managing this heterogeneous mental condition."

    Intra-Cellular Therapies is also presenting today additional analyses of Study ITI-007-301 in a poster at the International Society for CNS Clinical Trials and Methodologies (ISCTM) Annual Scientific Meeting that further demonstrate the strength of the Study 301 results.

    This poster presents a post-hoc sensitivity analysis of Study ITI-007-301 that assesses the sensitivity of the prospective Mixed-effect Model for Repeated Measures (MMRM) based analysis, which assumes missing data as missing-at-random (MAR), under the alternative assumption that missing data were missing-not-at-random (MNAR). There was a higher rate of early discontinuations due to lack of efficacy in the placebo group compared with the lumateperone-treated group, suggesting that the MAR assumption that underlies the MMRM analysis may result in an underestimation of the drug-placebo difference by at least 32%.  Using 3 other appropriate methods for dealing with imbalances in discontinuations due to lack of efficacy, lumateperone 42 mg was found to have substantially greater benefit compared with placebo than that obtained using the primary MMRM analysis, with drug-placebo differences of -6.2, -6.5, and -7.3 points on the PANSS in these analyses compared with -4.2 points in the primary analysis.  Results from these additional sensitivity analyses confirm the efficacy of lumateperone 42 mg compared with placebo in Study ‘301.

    About the ITI-007-301 Clinical Trial

    This randomized, double-blind, fixed-dose, placebo-controlled Phase 3 inpatient clinical trial was conducted at 12 sites in the United States with 450 patients randomized (1:1:1) to receive either CAPLYTA 42 mg or 28 mg or placebo once daily in the morning for four weeks. Patients were diagnosed with schizophrenia using DSM-5 criteria and were required to have an acute exacerbation of psychotic symptoms. The pre-specified primary efficacy measure was change from baseline at study endpoint (4 weeks) on the centrally rated PANSS total score. The key secondary endpoint was the centrally rated CGI-S. Trial participants had a mean PANSS score of 89.8 at baseline, indicative of being markedly ill. The 28 mg dose is not an approved dose for CAPLYTA.

    CAPLYTA (lumateperone) is indicated for the treatment of schizophrenia in adults.

    Important Safety Information

    Boxed Warning: Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. CAPLYTA is not approved for the treatment of patients with dementia-related psychosis.

    Contraindications: CAPLYTA is contraindicated in patients with known hypersensitivity to lumateperone or any components of CAPLYTA.

    Warnings & Precautions: Antipsychotic drugs have been reported to cause:

    • Cerebrovascular Adverse Reactions in Elderly Patients with Dementia-Related Psychosis, including stroke and transient ischemic attack. See Boxed Warning above.
    • Neuroleptic Malignant Syndrome, which is a potentially fatal reaction. Signs and symptoms include: hyperpyrexia, muscle rigidity, delirium, autonomic instability, elevated creatinine phosphokinase, myoglobinuria (and/or rhabdomyolysis), and acute renal failure. Manage with immediate discontinuation of CAPLYTA and close monitoring. 
    • Tardive Dyskinesia, a syndrome of potentially irreversible, dyskinetic, and involuntary movements which may increase as the duration of treatment and total cumulative dose increases. Discontinue CAPLYTA if clinically appropriate.
    • Metabolic Changes, including hyperglycemia, diabetes mellitus, dyslipidemia, and weight gain. Measure weight and assess fasting plasma glucose and lipids when initiating CAPLYTA and monitor periodically during long-term treatment.
    • Leukopenia, Neutropenia, and Agranulocytosis (including fatal cases). Perform complete blood counts in patients with pre-existing low white blood cell count (WBC) or history of leukopenia or neutropenia. Discontinue CAPLYTA if clinically significant decline in WBC occurs in absence of other causative factors.
    • Orthostatic Hypotension and Syncope. Monitor heart rate and blood pressure and warn patients with known cardiovascular or cerebrovascular disease.
    • Falls. CAPLYTA may cause somnolence, postural hypotension, and motor and/or sensory instability, which may lead to falls and, consequently, fractures and other injuries. Assess patients for risk when using CAPLYTA.
    • Seizures. Use CAPLYTA cautiously in patients with a history of seizures or with conditions that lower seizure threshold.
    • Potential for Cognitive and Motor Impairment. Advise patients to use caution when operating machinery or motor vehicles until they know how CAPLYTA affects them.
    • Body Temperature Dysregulation. Use CAPLYTA with caution in patients who may experience conditions that may increase core body temperature such as strenuous exercise, extreme heat, dehydration, or concomitant anticholinergics.
    • Dysphagia. Use CAPLYTA with caution in patients at risk for aspiration.

    Drug Interactions: Avoid concomitant use with CYP3A4 inducers and moderate or strong CYP3A4 inhibitors.

    Special Populations: Neonates exposed to antipsychotic drugs during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery. Breastfeeding is not recommended. Avoid use in patients with moderate or severe hepatic impairment.

    Adverse Reactions: The most common adverse reactions in clinical trials with CAPLYTA vs. placebo were somnolence/sedation (24% vs. 10%) and dry mouth (6% vs. 2%).

    Please see full Prescribing Information including Boxed Warning.

    About CAPLYTA (lumateperone)

    CAPLYTA is an oral, once daily medicine approved for the treatment of schizophrenia in adults (42mg/day).

    The mechanism of action of CAPLYTA in the treatment of schizophrenia is unknown. However, the efficacy of CAPLYTA could be mediated through a combination of antagonist activity at central serotonin 5-HT2A receptors and postsynaptic antagonist activity at central dopamine D2 receptors.

    CAPLYTA was approved for the treatment of schizophrenia in adults by the U.S. Food and Drug Administration in December 2019.

    About Intra-Cellular Therapies

    Intra-Cellular Therapies is a biopharmaceutical company founded on Nobel prize-winning research that allows us to understand how therapies affect the inner-workings of cells in the body. The company leverages this intracellular approach to develop innovative treatments for people living with complex psychiatric and neurologic diseases. For more information, please visit www.intracellulartherapies.com.

    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, the safety and efficacy of CAPLYTA and our other product candidates; that CAPLYTA represents an important addition to the treatment options of healthcare providers; 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: there are no guarantees that CAPLYTA will be commercially successful; we may encounter issues, delays or other challenges in launching or commercializing CAPLYTA; whether CAPLYTA receives adequate reimbursement from third-party payors; the degree to which CAPLYTA receives acceptance from patients and physicians for its approved indication; challenges associated with execution of our sales activities, which in each case could limit the potential of our product; results achieved in CAPLYTA in the treatment of schizophrenia once we have launched the product may be different than observed in clinical trials, and may vary among patients; risks associated with our current and planned clinical trials; we may encounter unexpected safety or tolerability issues with CAPLYTA following commercial launch for the treatment of schizophrenia or in ongoing or future trials and other development activities; 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.

    Contacts:

    Intra-Cellular Therapies, Inc.
    Juan Sanchez, M.D.
    Vice President, Corporate Communications and Investor Relations
    646-440-9333

    Burns McClellan, Inc.
    Lisa Burns
     
    212-213-0006

    MEDIA INQUIRIES:

    Ana Fullmer
    Corporate Media Relations W2Owcg

    202-507-0130

    Source: Intra-Cellular Therapies, Inc.

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  32. NEW YORK, Feb. 18, 2020 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (NASDAQ:ITCI), a biopharmaceutical company focused on the development and commercialization of therapeutics for central nervous system (CNS) disorders, today announced that Sharon Mates, Ph.D., Chief Executive Officer and Chairman, is scheduled to present at the 9th Annual SVB Leerink Global Healthcare Conference in New York. The presentation is scheduled for Tuesday, February 25, 2020 at 9:00 am ET.

    The live and archived webcast can be accessed under "Press Releases & Events" in the Investor Relations section of the Company's website at www.intracellulartherapies.com. Please log in approximately 5-10 minutes prior to the event to register and to download and install…

    NEW YORK, Feb. 18, 2020 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (NASDAQ:ITCI), a biopharmaceutical company focused on the development and commercialization of therapeutics for central nervous system (CNS) disorders, today announced that Sharon Mates, Ph.D., Chief Executive Officer and Chairman, is scheduled to present at the 9th Annual SVB Leerink Global Healthcare Conference in New York. The presentation is scheduled for Tuesday, February 25, 2020 at 9:00 am ET.

    The live and archived webcast can be accessed under "Press Releases & Events" in the Investor Relations section of the Company's website at www.intracellulartherapies.com. Please log in approximately 5-10 minutes prior to the event to register and to download and install any necessary software.

    About Intra-Cellular Therapies

    Intra-Cellular Therapies is a biopharmaceutical company founded on Nobel prize-winning research that allows us to understand how therapies affect the inner-workings of cells in the body. The company leverages this intracellular approach to develop innovative treatments for people living with complex psychiatric and neurologic diseases. For more information, please visit www.intracellulartherapies.com.

    Contact:

    Intra-Cellular Therapies, Inc.
    Juan Sanchez, M.D. 
    Vice President, Corporate Communications and Investor Relations
    646-440-9333

    Burns McClellan, Inc.
    Lisa Burns

    212-213-0006

    MEDIA INQUIRIES:

    Ana Fullmer
    Corporate Media Relations W2Owcg

    202-507-0130

    Primary Logo

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  33. NEW YORK, Jan. 07, 2020 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (NASDAQ:ITCI), a biopharmaceutical company, today announced the pricing of its previously announced underwritten public offering of 10,000,000 shares of its common stock at a public offering price of $29.50 per share. All of the shares in the offering will be sold by Intra-Cellular Therapies, with gross proceeds to Intra-Cellular Therapies expected to be $295 million from the offering of an aggregate of 10,000,000 shares before deducting underwriting discounts and commissions and offering expenses.

    Intra-Cellular Therapies has granted the underwriters a 30-day option to purchase up to an additional 1,500,000 shares on the same terms and conditions. The expected net…

    NEW YORK, Jan. 07, 2020 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (NASDAQ:ITCI), a biopharmaceutical company, today announced the pricing of its previously announced underwritten public offering of 10,000,000 shares of its common stock at a public offering price of $29.50 per share. All of the shares in the offering will be sold by Intra-Cellular Therapies, with gross proceeds to Intra-Cellular Therapies expected to be $295 million from the offering of an aggregate of 10,000,000 shares before deducting underwriting discounts and commissions and offering expenses.

    Intra-Cellular Therapies has granted the underwriters a 30-day option to purchase up to an additional 1,500,000 shares on the same terms and conditions. The expected net proceeds to Intra-Cellular Therapies referenced above do not include any net proceeds that Intra-Cellular Therapies would receive if the underwriters exercise such option. The offering is expected to close on January 10, 2020, subject to customary closing conditions.

    J.P. Morgan Securities LLC, SVB Leerink LLC and Evercore Group L.L.C. are acting as joint book-running managers for the offering. Cantor Fitzgerald & Co. and Canaccord Genuity LLC are acting as co-lead managers and JMP Securities LLC is acting as co-manager for the offering.

    The public offering is being made pursuant to a shelf registration statement on Form S-3 that was previously filed with the Securities and Exchange Commission (the "SEC") and became effective upon filing. A preliminary prospectus supplement and accompanying base prospectus relating to and describing the terms of the offering has been filed with the SEC and is available on the SEC's website located at http://www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to this offering, when available, can be obtained from J.P. Morgan Securities LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by telephone at 1-866-803-9204 or by email at ; SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA, 02110, by telephone at 1-800-808-7525, ext. 6132, or by email at ; or Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 36th Floor, New York, NY 10055, by telephone at (888) 474-0200 or by email at .

    This press release shall not constitute an offer to sell, or a solicitation of an offer to buy, nor will there be any sale of these securities in any state or other jurisdiction in which such an offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

    About Intra-Cellular Therapies

    Intra-Cellular Therapies is a biopharmaceutical company founded on Nobel prize-winning research that allows it to understand how therapies affect the inner-workings of cells in the body. The Company leverages this intracellular approach to develop innovative treatments for people living with complex psychiatric and neurologic diseases.

    Contact

    Intra-Cellular Therapies, Inc.
    Juan Sanchez, M.D.
    Vice President, Corporate Communications and Investor Relations
    646-440-9333

    Burns McClellan, Inc.
    Lisa Burns

    212-213-0006

     

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  34. NEW YORK, Jan. 06, 2020 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (NASDAQ:ITCI), a biopharmaceutical company, today announced that it has commenced an underwritten public offering of 10,000,000 shares of its common stock. In connection with the offering, Intra-Cellular Therapies intends to grant the underwriters a 30-day option to purchase up to an additional 15% of the shares of common stock offered in the public offering. All of the shares in the offering will be sold by Intra-Cellular Therapies.

    J.P. Morgan Securities LLC, SVB Leerink LLC and Evercore Group L.L.C. are acting as joint book-running managers for the offering. The offering is subject to market and other conditions, and there can be no assurance as to whether or when…

    NEW YORK, Jan. 06, 2020 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (NASDAQ:ITCI), a biopharmaceutical company, today announced that it has commenced an underwritten public offering of 10,000,000 shares of its common stock. In connection with the offering, Intra-Cellular Therapies intends to grant the underwriters a 30-day option to purchase up to an additional 15% of the shares of common stock offered in the public offering. All of the shares in the offering will be sold by Intra-Cellular Therapies.

    J.P. Morgan Securities LLC, SVB Leerink LLC and Evercore Group L.L.C. are acting as joint book-running managers for the offering. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

    The public offering will be made pursuant to a shelf registration statement on Form S-3 that was previously filed with the Securities and Exchange Commission (the "SEC") and became effective upon filing. A preliminary prospectus supplement and accompanying base prospectus relating to and describing the terms of the offering will be filed with the SEC and will be available on the SEC's website located at http://www.sec.gov. The offering is being made only by means of a prospectus and related prospectus supplement, copies of which may be obtained from J.P. Morgan Securities LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by telephone at 1-866-803-9204 or by email at , SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA, 02110, by telephone at 1-800-808-7525, ext. 6132, or by email at , or Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 36th Floor, New York, NY 10055, by telephone at (888) 474-0200 or by email at . The final terms of the offering will be disclosed in a final prospectus supplement to be filed with the SEC.

    This press release shall not constitute an offer to sell, or a solicitation of an offer to buy, nor will there be any sale of these securities in any state or other jurisdiction in which such an offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

    About Intra-Cellular Therapies

    Intra-Cellular Therapies is a biopharmaceutical company founded on Nobel prize-winning research that allows it to understand how therapies affect the inner-workings of cells in the body. The Company leverages this intracellular approach to develop innovative treatments for people living with complex psychiatric and neurologic diseases.

    Contact

    Intra-Cellular Therapies, Inc.
    Juan Sanchez, M.D.
    Vice President, Corporate Communications and Investor Relations
    646-440-9333

    Burns McClellan, Inc.
    Lisa Burns

    212-213-0006

    Primary Logo

    View Full Article Hide Full Article
  35. NEW YORK, Jan. 02, 2020 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (NASDAQ:ITCI), a biopharmaceutical company focused on the development of therapeutics for central nervous system (CNS) disorders, today announced that Sharon Mates, Ph.D., Chief Executive Officer and Chairman, is scheduled to present at the 38th Annual J.P. Morgan Healthcare Conference in San Francisco at the Westin St. Francis Hotel. The presentation is scheduled for Wednesday, January 15, 2020 at 8:30 am PST.

    The live and archived webcast can be accessed under "Press Releases & Events" in the Investor Relations section of the Company's website at www.intracellulartherapies.com. Please log in approximately 5-10 minutes prior to the event to register and to download…

    NEW YORK, Jan. 02, 2020 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (NASDAQ:ITCI), a biopharmaceutical company focused on the development of therapeutics for central nervous system (CNS) disorders, today announced that Sharon Mates, Ph.D., Chief Executive Officer and Chairman, is scheduled to present at the 38th Annual J.P. Morgan Healthcare Conference in San Francisco at the Westin St. Francis Hotel. The presentation is scheduled for Wednesday, January 15, 2020 at 8:30 am PST.

    The live and archived webcast can be accessed under "Press Releases & Events" in the Investor Relations section of the Company's website at www.intracellulartherapies.com. Please log in approximately 5-10 minutes prior to the event to register and to download and install any necessary software.

    About Intra-Cellular Therapies

    Intra-Cellular Therapies is a biopharmaceutical company founded on Nobel prize-winning research that allows us to understand how therapies affect the inner-workings of cells in the body. The company leverages this intracellular approach to develop innovative treatments for people living with complex psychiatric and neurologic diseases. For more information, please visit www.intracellulartherapies.com.

    Contact:

    Intra-Cellular Therapies, Inc.
    Juan Sanchez, M.D. 
    Vice President, Corporate Communications and Investor Relations
    646-440-9333

    Burns McClellan, Inc.
    Lisa Burns

    212-213-0006

    MEDIA INQUIRIES:

    Ana Fullmer
    Corporate Media Relations W2Owcg

    202-507-0130

    Primary Logo

    View Full Article Hide Full Article
  36. NEW YORK, Dec. 23, 2019 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (NASDAQ:ITCI), a biopharmaceutical company focused on the development of therapeutics for central nervous system (CNS) disorders, today announced that CAPLYTA® (lumateperone) has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of schizophrenia in adults. The Company expects to initiate the commercial launch of CAPLYTA in late Q1 2020.

    The efficacy of CAPLYTA 42 mg was demonstrated in two placebo-controlled trials, showing a statistically significant separation from placebo on the primary endpoint, the Positive and Negative Syndrome Scale (PANSS) total score. The most common adverse reactions (≥5% and twice the rate of placebo) for the…

    NEW YORK, Dec. 23, 2019 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (NASDAQ:ITCI), a biopharmaceutical company focused on the development of therapeutics for central nervous system (CNS) disorders, today announced that CAPLYTA® (lumateperone) has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of schizophrenia in adults. The Company expects to initiate the commercial launch of CAPLYTA in late Q1 2020.

    The efficacy of CAPLYTA 42 mg was demonstrated in two placebo-controlled trials, showing a statistically significant separation from placebo on the primary endpoint, the Positive and Negative Syndrome Scale (PANSS) total score. The most common adverse reactions (≥5% and twice the rate of placebo) for the recommended dose of CAPLYTA vs placebo were somnolence/sedation (24% vs.10%) and dry mouth (6% vs. 2%).

    In pooled data from short term studies, mean changes from baseline in weight gain, fasting glucose, triglycerides and total cholesterol were similar between CAPLYTA and placebo. The incidence of extrapyramidal symptoms was 6.7% for CAPLYTA and 6.3% for placebo.

    "We believe CAPLYTA provides healthcare providers a new, safe and effective treatment option to help the millions of adult patients with schizophrenia," said Dr. Sharon Mates, Chairman and CEO of Intra-Cellular Therapies. "This approval represents the culmination of years of scientific research. We are especially grateful to the patients, their caregivers, and the healthcare professionals who have contributed to the development of CAPLYTA."

    Schizophrenia is a serious mental illness impacting approximately 2.4 million adults in the United States. The clinical presentation of schizophrenia is diverse.  Acute episodes are characterized by psychotic symptoms, including hallucinations and delusions, often requiring hospitalization.  The disease is chronic and lifelong, often accompanied by depression and gradual deterioration of social functioning and cognitive ability. Patients with schizophrenia often discontinue treatment as a result of side effects such as weight gain and movement disorders.

    "Schizophrenia is a complex disease that severely impacts patients and their families," said Jeffrey A. Lieberman, M.D., Lawrence C. Kolb Professor and Chairman of Psychiatry, Columbia University, College of Physicians and Surgeons and Director, New York State Psychiatric Institute. "Effective treatment provided in a timely fashion can be game-changing for people living with schizophrenia. The efficacy and safety profile of CAPLYTA approved by the FDA, offers healthcare providers an important new option for treating people living with schizophrenia." 

    Please also see full Prescribing Information including Boxed Warning.

    Important Safety Information

    Boxed Warning: Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. CAPLYTA is not approved for the treatment of patients with dementia-related psychosis.

    Contraindications: CAPLYTA is contraindicated in patients with known hypersensitivity to lumateperone or any components of CAPLYTA.

    Warnings & Precautions: Antipsychotic drugs have been reported to cause:

    • Cerebrovascular Adverse Reactions in Elderly Patients with Dementia-Related Psychosis, including stroke and transient ischemic attack.  See BOXED WARNING above.
    • Neuroleptic Malignant Syndrome, which is a potentially fatal reaction. Signs and symptoms include: hyperpyrexia, muscle rigidity, delirium, autonomic instability, elevated creatinine phosphokinase, myoglobinuria (and/or rhabdomyolysis), and acute renal failure. Manage with immediate discontinuation of CAPLYTA and close monitoring. 
    • Tardive Dyskinesia, a syndrome of potentially irreversible, dyskinetic, and involuntary movements which may increase as the duration of treatment and total cumulative dose increases. Discontinue CAPLYTA if clinically appropriate.
    • Metabolic Changes, including hyperglycemia, diabetes mellitus, dyslipidemia, and weight gain. Measure weight and assess fasting plasma glucose and lipids when initiating CAPLYTA and monitor periodically during long-term treatment.
    • Leukopenia, Neutropenia, and Agranulocytosis (including fatal cases). Perform complete blood counts in patients with pre-existing low white blood cell count (WBC) or history of leukopenia or neutropenia. Discontinue CAPLYTA if clinically significant decline in WBC occurs in absence of other causative factors.
    • Orthostatic Hypotension and Syncope. Monitor heart rate and blood pressure and warn patients with known cardiovascular or cerebrovascular disease.
    • Falls. CAPLYTA may cause somnolence, postural hypotension, and motor and/or sensory instability, which may lead to falls and, consequently, fractures and other injuries. Assess patients for risk when using CAPLYTA.
    • Seizures. Use CAPLYTA cautiously in patients with a history of seizures or with conditions that lower seizure threshold.
    • Potential for Cognitive and Motor Impairment. Advise patients to use caution when operating machinery or motor vehicles until they are reasonably certain CAPLYTA therapy does not affect them adversely. 
    • Body Temperature Dysregulation. Use CAPLYTA with caution in patients who may experience conditions that may increase core body temperature such as strenuous exercise, extreme heat, dehydration, or concomitant anticholinergics.
    • Dysphagia. Use CAPLYTA with caution in patients at risk for aspiration.

    Drug Interactions: Avoid concomitant use with CYP3A4 inducers and moderate or strong CYP3A4 inhibitors.

    Special Populations: Neonates exposed to antipsychotic drugs during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery. Breastfeeding is not recommended.  Avoid use in patients with moderate or severe hepatic impairment.

    Adverse Reactions: The most common adverse reactions in clinical trials with CAPLYTA vs. placebo were somnolence/sedation (24% vs. 10%) and dry mouth (6% vs. 2%).

    About CAPLYTA (lumateperone)

    CAPLYTA is an oral, once daily medicine approved for the treatment of schizophrenia of adults (42mg/day).

    The mechanism of action of CAPLYTA in the treatment of schizophrenia is unknown. However, the efficacy of CAPLYTA could be mediated through a combination of antagonist activity at central serotonin 5-HT2A receptors and postsynaptic antagonist activity at central dopamine D2 receptors.

    CAPLYTA is being developed for the treatment of bipolar depression, behavioral disturbances in patients with dementia, including Alzheimer's disease, depression and other neuropsychiatric and neurological disorders. CAPLYTA has not been demonstrated to be safe and effective in these other areas. CAPLYTA was approved for the treatment of schizophrenia in adults by the U.S. Food and Drug Administration in December 2019.

    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's first product, CAPLYTA, has received FDA approval for the treatment of schizophrenia in adults and is in development for the treatment of bipolar depression, behavioral disturbances in patients with dementia, including Alzheimer's disease, depression and other neuropsychiatric and neurological disorders. Intra-Cellular Therapies 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, the initiation of the commercial launch of CAPLYTA, including the timing thereof, our belief that CAPLYTA provides healthcare providers a new, safe and effective treatment option to help the millions of adult patients with schizophrenia, our estimates of the number of adults in the United States impacted by schizophrenia, the safety and efficacy of CAPLYTA and our other product candidates; the potential for CAPLYTA to benefit patients suffering from a range of neuropsychiatric and neurodegenerative diseases 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: there are no guarantees that CAPLYTA will be commercially successful; we may encounter issues, delays or other challenges in launching or commercializing CAPLYTA; whether CAPLYTA receives adequate reimbursement from third-party payors; the degree to which CAPLYTA receives acceptance from patients and physicians for its approved indication; challenges associated with execution of our sales activities, which in each case could limit the potential of our product; results achieved in CAPLYTA in the treatment of schizophrenia once we have launched the product may be different than observed in clinical trials, and may vary among patients; risks associated with our current and planned clinical trials; we may encounter unexpected safety or tolerability issues with CAPLYTA following commercial launch for the treatment of schizophrenia or in ongoing or future trials and other development activities; 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.

    Contacts:

    Intra-Cellular Therapies, Inc.
    Juan Sanchez, M.D.
    Vice President, Corporate Communications and Investor Relations
    646-440-9333

    Burns McClellan, Inc.
    Lisa Burns

    212-213-0006

    MEDIA INQUIRIES:

    Ana Fullmer
    Corporate Media Relations W2Owcg

    202-507-0130

    Source: Intra-Cellular Therapies, Inc.

     

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  37. Bipolar depression:  Study 404, A Phase 3 Clinical Trial of lumateperone for the treatment of Bipolar Depression, investigating the potential of lumateperone as a new option for the treatment of depressive episodes in patients suffering from Bipolar I or Bipolar II disorder. 

    Schizophrenia: Lumateperone's clinical profile including its motor and cardiometabolic profile was showcased in pooled analyses of randomized short-term clinical trials and a long-term safety study.

    Lumateperone and the Metabolic Syndrome (MetSy): Post-hoc analyses from short-term placebo-controlled studies in schizophrenia on MetSy in patients treated with lumateperone and in patients treated with risperidone were presented.

    NEW YORK, Dec. 12, 2019 (GLOBE NEWSWIRE…

    Bipolar depression:  Study 404, A Phase 3 Clinical Trial of lumateperone for the treatment of Bipolar Depression, investigating the potential of lumateperone as a new option for the treatment of depressive episodes in patients suffering from Bipolar I or Bipolar II disorder. 

    Schizophrenia: Lumateperone's clinical profile including its motor and cardiometabolic profile was showcased in pooled analyses of randomized short-term clinical trials and a long-term safety study.

    Lumateperone and the Metabolic Syndrome (MetSy): Post-hoc analyses from short-term placebo-controlled studies in schizophrenia on MetSy in patients treated with lumateperone and in patients treated with risperidone were presented.

    NEW YORK, Dec. 12, 2019 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (NASDAQ:ITCI), a biopharmaceutical company focused on the development of therapeutics for central nervous system (CNS) disorders, today announced data featured yesterday during the 58th Annual Meeting of the American College of Neuropsychopharmacology (ACNP) held in Orlando, FL, December 8-11, 2019 included:

    • "Lumateperone (ITI-007) in the Treatment of Bipolar Depression: Results from a Randomized Clinical Trial" (Poster W123)

    This poster presented data from the positive Phase 3 clinical trial of lumateperone for the treatment of patients with bipolar depression (ITI-007-404 or Study ‘404). Study 404 was conducted globally, including in the U.S., and included 381 patients randomized (1:1) to receive lumateperone 42 mg or placebo once daily for six weeks.  Lumateperone met its primary endpoint of change from baseline at Week 6 on the Montgomery-Åsberg Depression Rating Scale (MADRS) total score versus placebo (p<0.0001; effect size (ES) = 0.56). In the intent-to-treat study population, the LS mean improvement from baseline for lumateperone 42 mg was 16.7 points, versus 12.1 points for placebo, for a 4.6-point difference between the two groups. Lumateperone also met the study's key secondary endpoint, Clinical Global Impression Scale for Bipolar for Severity of Illness (CGI-BP-S) Total Score (p<0.001; ES = 0.46).  In addition, the CGI component that specifically assesses depression showed improvement with lumateperone versus placebo (CGI-BP-S Depression Score; p<0.001; ES = 0.50). This improvement was statistically significant as early as week 1, the first time point measured, and was maintained at every time point throughout the study.

    In subgroup analyses of both Bipolar I patients and Bipolar II patients, statistically significant improvements were seen versus placebo on the MADRS total score (Bipolar I patients: p<.0001; ES: 0.49; and Bipolar II patients: p<.001; ES: 0.81).

    These results were supported by statistically significant improvements on responder rates and remission rates, demonstrating the clinical meaningfulness of the primary outcome, with 51.1% of patients on lumateperone meeting MADRS response criteria (50% improvement from baseline) versus 36.7% for placebo at Day 43 (p<0.001). Additionally, 39.9% of patients on lumateperone were considered remitters (MADRS ≤12) versus 33.5% for placebo (p=<0.05).   

    The safety profile in this study was consistent with previously reported placebo-controlled and open-label studies in patients with schizophrenia. Lumateperone showed similar effects as placebo on assessments of body weight, metabolic parameters, extrapyramidal symptoms, and prolactin.  Rates of akathisia, restlessness and extrapyramidal symptoms combined were less than 1% and similar to placebo. The most commonly reported adverse events that were observed at a rate greater than 5% and higher than placebo were somnolence (8.5%) and nausea (6.4%). The rates of discontinuation due to treatment emergent adverse events for lumateperone were less than 5 percent.

    "The results of this trial including lumateperone's separation from placebo on multiple measures of depression accompanied by its metabolic and motor profile are impressive," said Joseph Calabrese, MD, Director, Mood Disorders Program, Department of Psychiatry, University Hospitals Cleveland Medical Center. "Lumateperone represents a potential important option for the treatment of patients suffering from Bipolar I and Bipolar II disorder who are experiencing depressive episodes.  These are highly prevalent and difficult to treat conditions for which there is a need for effective and better tolerated options." 

    • "Efficacy and Safety of Lumateperone 42 mg in the Treatment of Schizophrenia: A Pooled Analysis of Randomized Clinical Trials" (Poster W201)

    This poster highlighted the clinical results of lumateperone 42 mg, including its safety and tolerability profile from the short-term controlled studies of lumateperone in the treatment of patients with acute exacerbations of schizophrenia. The poster included additional post-hoc pooled analyses that found lower rates of MetSy in patients treated with lumateperone than in patients treated with risperidone.

    In these double-blind, placebo-controlled studies of 4 to 6 weeks duration, patients were randomized to either lumateperone 42mg (n=406), risperidone 4mg (n=255) or placebo (n=412). The percentage of patients meeting criteria for MetSy at baseline was similar across groups (18.2% for lumateperone, 19.2% for risperidone and 17.0% for placebo).

    At study endpoint, fewer patients on lumateperone met the MetSy criteria compared with the percentage on risperidone (15.0% v. 24.7%). Among those patients with MetSy at baseline, the percentage who no longer met criteria for MetSy after study treatment was nearly twice as high among patients treated with lumateperone as among patients treated with risperidone (45.9% v. 24.5%).  Among patients without MetSy at baseline, the percentage that developed MetSy during study treatment with lumateperone was half that in risperidone-treated patients (6.3% v. 12.6%).

    "Metabolic Syndrome is a highly prevalent set of risk factors among patients with schizophrenia and is associated with many commonly prescribed antipsychotics," said Dr. Christoph Correll, Professor of Psychiatry and Molecular Medicine at the Zucker School of Medicine at Hofstra/Northwell, New York. "Previous data have indicated that lumateperone is associated with effects similar to placebo in short-term trials on body weight and cardiometabolic parameters, including levels of blood glucose, insulin, and cholesterol. Moreover, in a switch safety study, lumateperone was associated with improvements in several important cardiometabolic parameters.  These new safety analyses in the broader context of a well-recognized clinical entity, the Metabolic Syndrome, which is a well-established marker for overall cardiovascular risk, are encouraging."

    • "Additional Results from a 12-Month Open-Label Safety Study of Lumateperone (ITI-007) in Patients with Stable Symptoms of Schizophrenia" (Poster W203).

    Additional results from the lumateperone long-term safety study were presented. The data presented showed the safety of long-term lumateperone treatment was consistent with previously reported studies and associated with a low risk of metabolic, EPS, and prolactin side effects. Patients with stable schizophrenia symptoms continued to show improvement in PANSS scores with lumateperone treatment throughout the 1-year open-label study. Furthermore, in patients with schizophrenia and comorbid depression symptoms at baseline lumateperone 42 mg improved depressive symptoms.

    About Lumateperone Bipolar Depression Program

    The lumateperone clinical trial program in bipolar depression includes three Phase 3 trials. Two trials, Study 401 and Study 404, evaluated lumateperone as monotherapy and the third trial, Study 402, is evaluating lumateperone as an adjunctive therapy to lithium or valproate. The safety and efficacy of lumateperone in bipolar disorder has not been established. 

    About Metabolic Syndrome (MetSy)

    According to the National Heart, Lung, and Blood Institute, MetSy is defined as the presence of at least 3 of the following 5 risk factors:  abdominal obesity as measured by waist circumference; elevated triglyceride levels; low HDL cholesterol levels; high blood pressure; and elevated fasting blood sugar.  People who meet this definition have 5-6 times the risk of developing type 2 diabetes and a 3-6 times increased risk of mortality due to coronary heart disease than people who do not1. People with severe mental illness have significantly higher rates of the MetSy than the general population2 and are likely to die 12-15 years earlier, with cardiovascular disease as the primary driver for this early mortality3.  A major factor in the development of MetSy among people with severe mental illness is the use of antipsychotic medication4.

    References

    1. Alberti K, Eckel RH, Grundy SM, et al.  Harmonizing the metabolic syndrome:  a joint interim statement of the International Diabetes Federation Task Force on Epidemiology and Prevention; National Heart, Lung, and Blood Institute; American Heart Association; World Heart Federation; International Atherosclerosis Society; and International Association for the Study of Obesity.  Circulation 2009;120(16):1640-1645
    2. Vancampfort D, Stubbs B, Mitchell AJ, De Hert M, Wampers M, Ward PB, Rosenbaum S, Correll CU. Risk of metabolic syndrome and its components in people with schizophrenia and related psychotic disorders, bipolar disorder and major depressive disorder: a systematic review and meta-analysis. World Psychiatry 2015;14(3):339-47.
    3. Correll CU, Solmi M, Veronese N, et al.  Prevalence, incidence and mortality from cardiovascular disease in patients with pooled and specific severe mental illness:  a large-scale meta-analysis of 3,211,768 patients and 113,383,368 controls.  World Psychiatry 2017;16(2):163-180
    4. De Hert M, Detraux J, van Winkel R, Yu W, Correll CU. Metabolic and cardiovascular adverse effects associated with antipsychotic drugs. Nat Rev Endocrinol 2011;8(2):114-26.

    About Lumateperone

    Lumateperone is an investigational molecule that provides selective and simultaneous modulation of serotonin, dopamine, and glutamate - three neurotransmitter pathways implicated in severe mental illness. Lumateperone is a potent serotonin 5-HT2A receptor antagonist, a dopamine receptor phosphoprotein modulator (DPPM) acting as a presynaptic partial agonist and postsynaptic antagonist at dopamine D2 receptors, a dopamine D1 receptor-dependent indirect modulator of glutamate (both NDMA and AMPA), and a serotonin reuptake inhibitor.  Lumateperone in an investigational new drug under review with the FDA for the treatment of schizophrenia, its safety and efficacy has not been established, and it has not been approved for marketing for any use by the U.S. Food and Drug Administration (FDA) or any other regulatory authority in any other jurisdiction.  

    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 is under review by the FDA for the treatment of schizophrenia and is in Phase 3 clinical development for the treatment of bipolar depression. Intra-Cellular Therapies 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, the safety and efficacy of our product candidates; the potential benefits and uses of our product candidates 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: whether the NDA for lumateperone for the treatment of schizophrenia will be approved by the FDA and whether the FDA will complete its review within the target timelines including the new PDUFA goal date; whether, during its review of our applications for regulatory approval of our product candidates, we will be able to provide in a timely manner all information requested by the FDA and whether the FDA will determine information we submit in the course of such reviews is satisfactory; risks associated with our current and planned clinical trials; we may encounter unexpected safety or tolerability issues with lumateperone in ongoing or future trials and other development activities; 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

    212-213-0006

    MEDIA INQUIRIES:

    Ana Fullmer
    Corporate Media Relations W2Owcg

    202-507-0130

    Primary Logo

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  38. NEW YORK, Dec. 04, 2019 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (NASDAQ:ITCI), a biopharmaceutical company focused on the development of therapeutics for central nervous system (CNS) disorders, today announced that the Company will be presenting at the 58th Annual Meeting of the American College of Neuropsychopharmacology (ACNP) to be held in Hollywood, FL, December 8-11, 2019.

    Intra-Cellular Therapies will be presenting the following posters and presentations at ACNP, which will include results from Study 404, a Phase 3 clinical trial evaluating lumateperone for the treatment of bipolar depression, as well as new data from the schizophrenia clinical program including the long-term safety study. Lumateperone is a novel investigational…

    NEW YORK, Dec. 04, 2019 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (NASDAQ:ITCI), a biopharmaceutical company focused on the development of therapeutics for central nervous system (CNS) disorders, today announced that the Company will be presenting at the 58th Annual Meeting of the American College of Neuropsychopharmacology (ACNP) to be held in Hollywood, FL, December 8-11, 2019.

    Intra-Cellular Therapies will be presenting the following posters and presentations at ACNP, which will include results from Study 404, a Phase 3 clinical trial evaluating lumateperone for the treatment of bipolar depression, as well as new data from the schizophrenia clinical program including the long-term safety study. Lumateperone is a novel investigational drug currently under review by the FDA as a potential treatment for adults with schizophrenia. Preclinical data on ITI-333, our novel compound with high affinity at serotonin 5-HT2A, dopamine D1 and mu opioid (MOP) receptors for the potential treatment of substance use disorders and pain will also be presented.

    Oral Presentation

    Tuesday, December 10, 2019, 4:55 pm – 5:30 p.m. ET during panel "Responses to the Opioid Epidemic: Government, Industry and Academic Perspectives".

    • "ITI-333: An Investigational Drug for the Treatment of Opioid Use Disorder". Presented by Kimberly Vanover Ph.D., Senior Vice President, Translational Medicine and Early Stage Clinical Development, at ITCI.

    Wednesday, December 11, 2019, 5:30 pm - 7:30 p.m. ET during Poster Session III.

    • "Lumateperone (ITI-007) in the Treatment of Bipolar Depression: Results from a Randomized Clinical Trial" (Poster W123). Authors include: S. Durgam; A. Satlin; K. Vanover; R. Davis; S. Kozauer; R. Chen; S. Mates; J. R. Calabrese.
    • "Additional Results from a 12-Month Open-Label Safety Study of Lumateperone (ITI-007) in Patients with Stable Symptoms of Schizophrenia" (Poster W203). Authors include: A. Satlin; K. Vanover; S. Durgam; S. Mates; R. Davis; C. Correll.
    • "Efficacy and Safety of Lumateperone 42 mg in the Treatment of Schizophrenia: A Pooled Analysis of Randomized Clinical Trials" (Poster W 201). Authors include: K. Vanover; J. Kane; A. Satlin; S. Durgam; R. Davis; S. Mates; C. Correll; C. Tamminga.

    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 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.

    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, the safety and efficacy of our product development candidates; the potential for lumateperone to benefit patients suffering from a range of neuropsychiatric and neurodegenerative diseases 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: whether the NDA for lumateperone for the treatment of schizophrenia will be approved by the FDA and whether the FDA will complete its review within the target timelines; the risk that the NDA will not be approved despite the FDA's acceptance of the NDA for review or that the FDA will require additional information; risks associated with our current and planned clinical trials; we may encounter unexpected safety or tolerability issues with lumateperone in ongoing or future trials and other development activities; 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

    212-213-0006

    MEDIA INQUIRIES:
    Ana Fullmer
    Corporate Media Relations W2Owcg

    202-507-0130

    Primary Logo

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  39. NEW YORK, Sept. 30, 2019 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (NASDAQ:ITCI), a biopharmaceutical company focused on the development of therapeutics for central nervous system (CNS) disorders, today announced that Sharon Mates, Ph.D., Chief Executive Officer and Chairman, is scheduled to present at the 2019 Cantor Global Healthcare Conference in New York. The presentation is scheduled for Wednesday, October 2, 2019 at 10:40 am ET.

    The live and archived webcast can be accessed under "Press Releases & Events" in the Investor Relations section of the Company's website at www.intracellulartherapies.com. Please log in approximately 5-10 minutes prior to the event to register and to download and install any necessary software.

    About Intra-Cellular

    NEW YORK, Sept. 30, 2019 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (NASDAQ:ITCI), a biopharmaceutical company focused on the development of therapeutics for central nervous system (CNS) disorders, today announced that Sharon Mates, Ph.D., Chief Executive Officer and Chairman, is scheduled to present at the 2019 Cantor Global Healthcare Conference in New York. The presentation is scheduled for Wednesday, October 2, 2019 at 10:40 am ET.

    The live and archived webcast can be accessed under "Press Releases & Events" in the Investor Relations section of the Company's website at www.intracellulartherapies.com. Please log in approximately 5-10 minutes prior to the event to register and to download and install any necessary software.

    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 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.

    Contact:

    Intra-Cellular Therapies, Inc.
    Juan Sanchez, M.D. 
    Vice President, Corporate Communications and Investor Relations
    646-440-9333

    Burns McClellan, Inc.
    Lisa Burns

    212-213-0006

    Primary Logo

    View Full Article Hide Full Article
  40. Data indicate ITI-214 at a dose of 30 mg is well tolerated with a favorable safety profile

    Study ‘104 now proceeding to a third cohort at a dose of 90 mg

    NEW YORK, Sept. 25, 2019 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (NASDAQ:ITCI) today announced the successful completion of the second dose cohort (single dose of 30 mg administered orally) in Study ITI-214-104 (Study ‘104), a proof-of-mechanism, translational medicine study of ITI-214, a novel phosphodiesterase-1 (PDE1) inhibitor, in patients with chronic heart failure.  Clinical conduct of the third and last cohort, 90 mg, is now ongoing following review of safety and tolerability data from the 30 mg dose cohort, where no safety concerns were identified.

    Study ‘104 is a randomized…

    Data indicate ITI-214 at a dose of 30 mg is well tolerated with a favorable safety profile

    Study ‘104 now proceeding to a third cohort at a dose of 90 mg

    NEW YORK, Sept. 25, 2019 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (NASDAQ:ITCI) today announced the successful completion of the second dose cohort (single dose of 30 mg administered orally) in Study ITI-214-104 (Study ‘104), a proof-of-mechanism, translational medicine study of ITI-214, a novel phosphodiesterase-1 (PDE1) inhibitor, in patients with chronic heart failure.  Clinical conduct of the third and last cohort, 90 mg, is now ongoing following review of safety and tolerability data from the 30 mg dose cohort, where no safety concerns were identified.

    Study ‘104 is 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.  The primary objective of the study is to determine effects of ITI-214 on cardiac contractility and cardiac output in patients already maintained on standard-of-care treatment for chronic heart failure. 

    Initiation of Study 104 followed findings that ITI-214 improved cardiac output through a different mechanism of action than available heart failure therapies.  These findings in a preclinical model of heart failure were published by researchers at Johns Hopkins University and ITCI scientists in the journal Circulation.  Currently available heart failure drugs that strengthen heart contractions, such as the PDE3 inhibitors (amrinone and milrinone) and ß-adrenergic agonists (dobutamine), increase calcium entry into cardiac muscle cells and have potentially dangerous complications, such as irregular heartbeats. Unlike these drugs, ITI-214 did not cause calcium levels to rise in cardiomyocyte cells and did not interact with the ß-adrenergic signaling pathway. These experimental results demonstrate that ITI-214 exerts its effects via a separate pathway involving adenosine A2B receptor signaling, previously shown to be cardioprotective, and suggest that ITI-214 may represent a novel and potentially safer approach for the treatment of human heart failure.

    "We are encouraged by the continuing safety of ITI-214 in patients with heart failure and our progress toward completion of this important mechanistic study," said Sharon Mates Ph.D., Chairman and CEO of Intra-Cellular Therapies, Inc. "We believe ITI-214 offers a potential new treatment for heart failure with a novel mechanism."

    About Study ITI-214-104

    Study ‘104 is a randomized, double-blind, placebo-controlled study of escalating single doses of oral ITI-214 to evaluate hemodynamic effects and safety in patients with systolic heart failure (NYHA class II-III heart failure). This single dose ascending Study evaluates three dose cohorts of ITI-214: 10 mg, 30 mg and 90 mg with 12 patients per cohort randomized to ITI-214 or placebo 9:3.  The primary objective of the study is to determine effects of ITI-214 on cardiac contractility and cardiac output using echocardiogram with doppler imaging and hemodynamic monitoring in patients already maintained on standard-of-care treatment for chronic heart failure. Secondary objectives include safety and tolerability. This Study is being conducted at Johns Hopkins University and Duke Clinical Research Institute.

    About Heart Failure

    Heart failure affects about 5.7 million U.S. adults, according to the U.S. Centers for Disease Control and Prevention and contributes to an estimated one in nine deaths.  Human heart failure is a chronic condition often marked by weakening of the heart muscle and its subsequent failure to pump enough blood. Currently, drugs are available to treat or manage heart failure symptoms, but drugs that improve the strength of the heart muscle's contractions, carry the risk of dangerous complications such as developing irregular heartbeats. There is no cure. PDE1 inhibition may provide a new approach to treating heart failure that may not have the adverse events currently seen in available drugs.   

    About ITI-214

    ITI-214, is a potent and selective phosphodiesterase type 1 (PDE1) inhibitor. ITI-214 is the lead compound in the Company's PDE1 portfolio and is in development for the treatment of symptoms associated with Parkinson's disease and for the treatment of heart failure. ITI-214 has been found to be generally well tolerated with a favorable safety profile in four Phase 1 clinical trials. ITI-214 works by slowing the breakdown of cyclic nucleotides (cAMP, cGMP), allowing these molecules to build up in the cells and to exert important functions. The PDE1 enzyme is highly active in pathological or disease states, and our PDE1 molecules are designed to reestablish normal function in these disease states through the inhibition of the PDE1 enzyme. ITI-214 may allow precise adjustment of cAMP and/or cGMP in cells in which it is present.  In heart disease, excessive PDE1 activity may limit the beneficial effects of cAMP or cGMP, so inhibitors like ITI-214, have the potential to act as a therapy. Previous studies have described the mechanism of action of ITI-214 in the brain. The mechanism of action of ITI-214 suggests therapeutic potential across a variety of neurological and cardiovascular diseases.

    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 is under review by the FDA for the treatment of schizophrenia and is in Phase 3 clinical development for the treatment of bipolar depression. Intra-Cellular Therapies 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, the therapeutic value, clinical and non-clinical development plans and commercial potential of our drug product candidates; the progress, timing and results of our clinical trials and preclinical studies; our beliefs about the extent to which the results of our clinical trials and preclinical studies to date support new drug application filings for product candidates; the safety and efficacy of our product development candidates; our beliefs about the potential uses and benefits of our drug product candidates; that ITI-214 may represent a novel and potentially safer approach for the treatment of human heart failure; that ITI-214 offers a potential new treatment for heart failure with a novel mechanism 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 our 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

    212-213-0006

    MEDIA INQUIRIES:

    Jennifer Paganelli
    Corporate Media Relations, W2Owcg

    347-658-8290

    Primary Logo

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  41. FDA has informed the Company it has no plans to schedule an Advisory Committee Meeting

    Company has completed submission of non-clinical information previously agreed with FDA 

    NEW YORK, Sept. 10, 2019 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (NASDAQ:ITCI), a biopharmaceutical company focused on the development of therapeutics for central nervous system (CNS) disorders, today announced that the U.S. Food and Drug Administration (FDA) has informed the Company that it does not have plans to schedule an Advisory Committee meeting in connection with its review of the Company's New Drug Application (NDA) for lumateperone for the treatment of schizophrenia. The lumateperone Prescription Drug User Fee Act (PDUFA) goal date is December 27…

    FDA has informed the Company it has no plans to schedule an Advisory Committee Meeting

    Company has completed submission of non-clinical information previously agreed with FDA 

    NEW YORK, Sept. 10, 2019 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (NASDAQ:ITCI), a biopharmaceutical company focused on the development of therapeutics for central nervous system (CNS) disorders, today announced that the U.S. Food and Drug Administration (FDA) has informed the Company that it does not have plans to schedule an Advisory Committee meeting in connection with its review of the Company's New Drug Application (NDA) for lumateperone for the treatment of schizophrenia. The lumateperone Prescription Drug User Fee Act (PDUFA) goal date is December 27, 2019.

    Additionally, the Company recently submitted to the FDA the results of non-clinical analyses the Company previously announced it had agreed to conduct related to toxicology findings in animal studies. The Company believes the results of these analyses provide additional support for its position that the metabolic pathway, and the metabolites formed, are different in animals and humans and therefore toxicity findings in animals are not relevant to humans. 

    "We have been working diligently to address the FDA requests for information and are optimistic that the additional non-clinical information we submitted addresses those requests," said Dr. Sharon Mates, Chairman and CEO of Intra-Cellular Therapies. "There is an ongoing unmet need for new treatments for schizophrenia and we look forward to continuing our work with the FDA to bring lumateperone to patients."

    About Lumateperone

    Lumateperone, our lead product candidate, is a molecule that provides selective and simultaneous modulation of serotonin, dopamine, and glutamate - three neurotransmitter pathways implicated in severe mental illness. Lumateperone is a potent serotonin 5-HT2A receptor antagonist, a dopamine receptor phosphoprotein modulator (DPPM) acting as a presynaptic partial agonist and postsynaptic antagonist at dopamine D2 receptors, a dopamine D1 receptor-dependent indirect modulator of glutamate (both NDMA and AMPA), and a serotonin reuptake inhibitor. Lumateperone is an investigational new drug and has not been approved for marketing for any use by the FDA or any other regulatory authority in any other jurisdiction.  

    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 is under review by the FDA for the treatment of schizophrenia and is in Phase 3 clinical development for the treatment of bipolar depression. Intra-Cellular Therapies 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, the safety, tolerability and efficacy of our product candidates; the PDUFA goal date for the FDA's review of the lumateperone NDA; the FDA's indication that it has no plans to schedule an Advisory Committee meeting; our belief that the results of the analyses conducted provide additional support for its position that those findings are not relevant to humans; our belief that the analyses conducted further confirm that the metabolic pathway, and the metabolites formed, are different in animals and humans; our belief that the additional non-clinical information we submitted to the FDA addresses the FDA requests; the potential for lumateperone to provide benefits in a broad range of neuropsychiatric conditions; 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: whether the NDA for lumateperone for the treatment of schizophrenia will be approved by the FDA and whether the FDA will complete its review within the target timelines, including the PDUFA goal date; the risk that the NDA will not be approved despite the FDA's acceptance of the NDA for review; whether the FDA will require additional information, whether we will be able to provide in a timely manner any additional information that the FDA requests, and whether such additional information will be satisfactory to the FDA; the possibility that the FDA re-evaluates its plans not to schedule an Advisory Committee meeting and the risk that any such Advisory Committee meeting will negatively impact the approval of the NDA for lumateperone; risks associated with our current and planned clinical trials; we may encounter unexpected safety or tolerability issues with lumateperone in ongoing or future trials and other development activities; 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

    212-213-0006

    MEDIA INQUIRIES:

    Jennifer Paganelli
    Corporate Media Relations, W2Owcg

    347-658-8290

    Primary Logo

    View Full Article Hide Full Article