Diabetic Coma

Full year 2023 total revenues of $464.4 million, compared to $250.3 million in 2022 Full year 2023 CAPLYTA net product sales were $462.2 million, representing year-over-year growth of 86%. CAPLYTA fourth quarter 2023 net product sales grew to $131.5 million, a 50% increase over the same period in 2022 In 2023, CAPLYTA total prescriptions achieved strong year-over-year growth of 85% CAPLYTA 2024 net product sales guidance of $645 to $675 million NEW YORK, Feb. 22, 2024 (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, 2023 and provided a corporate update. “I am very proud of our accomplishments in 2023, including the continued strong uptake of CAPLYTA. In the year ahead, we are focused on continuing CAPLYTA’s momentum and advancing our pipeline. We look forward to the upcoming CAPLYTA Phase 3 read outs in adjunctive MDD and the potential to help a growing number of patients,” said Dr. Sharon Mates, Chairman and CEO of Intra-Cellular Therapies. FINANCIAL HIGHLIGHTS: Net product sales of CAPLYTA were $462.2 million for the full year 2023. This represents an increase of 86% compared to 2022. This growth was fueled by strong underlying prescription demand which grew 85% year-over-year in 2023. For the fourth quarter 2023, CAPLYTA net product sales reached $131.5 million representing a 50% increase over the fourth quarter of 2022.Net loss for the year ended December 31, 2023 was $139.7 million or $1.46 per share (basic and diluted) compared to a net loss of $256.3 million or $2.72 per share (basic and diluted) for the year ended December 31, 2022. Net loss for the fourth quarter of 2023 was $28.6 million compared to a net loss of $44.0 million for the same period in 2022.Selling, general and administrative (SG&A) expenses were $409.9 million for the year ended December 31, 2023, compared to $358.8 million for the year ended December 31, 2022. This increase is primarily due to an increase in commercialization, marketing and advertising costs. Research and development (R&D) expenses were $180.1 million for the year ended December 31, 2023, compared to $134.7 million for the year ended December 31, 2022. This increase is primarily due to higher lumateperone clinical and non-clinical project costs, and higher non-lumateperone project costs, including the ITI-1284, ITI-214, and ITI-333 programs.Cash, cash equivalents, restricted cash and investment securities totaled $499.7 million at December 31, 2023, compared to $593.7 million at December 31, 2022. Full Year 2024 Financial Outlook: CAPLYTA 2024 net product sales are expected to be $645 to $675 million.SG&A expenses for the full year 2024 are expected to be $450 to $480 million, including approximately $42.5 million of non-cash, share-based compensation expense. SG&A guidance reflects our commitment to continue to effectively and efficiently support CAPLYTA commercialization through investments in our sales and marketing activities.R&D expenses for the full year 2024 are expected to be $215 to $240 million, including approximately $20 million of non-cash, share-based compensation expense. Our R&D guidance reflects investments to support our broad pipeline. In 2024, we anticipate that a large portion of our total R&D expenditures will be related to our lumateperone development programs as we continue to explore the use of lumateperone in additional patient populations. 2024 Guidance(in $ millions) low highCAPLYTA Net Product Sales (GAAP)$645 $675SG&A expenses (GAAP)$450 $480R&D expenses (GAAP)$215 $240 COMMERCIAL HIGHLIGHTS Successfully continued the launch of CAPLYTA for the treatment of bipolar depression in adults. In 2023, CAPLYTA strong prescription demand continued with 85% total prescription growth over 2022. In the fourth quarter, total prescriptions of CAPLYTA increased 55% over the same period in 2022, and 10% sequentially over the third quarter of 2023. In 2023, we continued to improve market access for CAPLYTA across all three major channels. Our market access for CAPLYTA covers approximately 90% of commercially insured lives and greater than 99% of the Medicare Part D and Medicaid lives.Our LytaLink patient and prescriber support program continues to be very effective in supporting patient access to CAPLYTA. CLINICAL HIGHLIGHTS Lumateperone: Adjunctive MDD program: Studies 501, 502 and 505 are our global Phase 3 clinical trials evaluating lumateperone 42 mg as an adjunctive therapy to antidepressants for the treatment of major depressive disorder. Study 501 is fully enrolled and most patients have completed treatment. We allowed the small number of patients who were in screening when we reached our previously determined enrollment target to continue and be randomized to the double-blind treatment phase of the study. As a result, we expect to report topline results from Study 501 in April of this year. In addition, we expect to report topline results from Study 502 late in the second quarter of this year. Subject to those results, we continue to anticipate filing a supplemental New Drug Application with the FDA in the second half of 2024. Mixed Features program: In 2023, we reported robust positive results from Study 403, our clinical trial evaluating lumateperone in patients with major depressive disorder exhibiting mixed features and patients with bipolar depression exhibiting mixed features In this study, lumateperone 42 mg was statistically significant on the primary endpoint of symptom reduction on the Montgomery Asberg Depression Rating Scale (MADRS) for the combined mixed features patient population of MDD and bipolar depression and the individual patient populations of MDD with mixed features and bipolar depression with mixed features. The robust effect sizes ranged from 0.64 to 0.67. Lumateperone was generally safe and well tolerated, with a side effect profile consistent with prior trials. There were no notable changes in weight, body mass index or waist circumference and no clinically relevant changes in metabolic parameters. Last year, we presented results from Study 403 at several medical conferences including the Psych Congress, the European College of Neuropsychopharmacology Congress and the American College of Neuropsychopharmacology annual meeting. Lumateperone pediatric program: We have commenced our lumateperone pediatric program. This program includes an open-label safety study in schizophrenia and bipolar disorder; a double-blind, placebo-controlled study in bipolar depression and two double-blind, placebo-controlled studies in irritability associated with autism spectrum disorder. The patient enrollment in the open-label safety study has commenced. Lumateperone Long Acting Injectable (LAI) formulation: The goal of the program is to develop LAI formulations that are effective, safe, and well-tolerated with treatment durations of one month or longer. For our first LAI formulation, we have completed the pre-clinical development and conducted a Phase 1 single ascending dose study. We expect to initiate a Phase 1 single ascending dose study with four additional formulations in the first half of 2024. Other pipeline programs: ITI-1284-ODT-SL program: ITI-1284 is a deuterated form of lumateperone, a new chemical entity formulated as an oral disintegrating tablet for sublingual administration. In 2023, we advanced several Phase 1 studies. We have initiated Phase 2 programs evaluating ITI-1284 in generalized anxiety disorder (GAD), psychosis in Alzheimer’s disease, and agitation in Alzheimer’s disease and anticipate commencing patient enrollment in the first half of 2024. Phosphodiesterase type I inhibitor (PDE1) program: Our portfolio of PDE1 inhibitors continues to advance clinical development. Lenrispodun (ITI-214) Parkinson’s disease (PD) program: Patient enrollment in our Phase 2 clinical trial is ongoing. The objective of this study is to evaluate improvements in motor symptoms in patients with PD. Changes in cognition and inflammatory biomarkers are also being assessed. We expect to complete patient enrollment in late 2024 with topline results anticipated in the first half of 2025. ITI-1020 cancer immunotherapy program: Our Phase 1 single ascending dose study in healthy volunteers is progressing. The objective of this study is to evaluate pharmacokinetics, safety, and tolerability of different doses of ITI-1020. ITI-333 program: ITI-333, a 5-HT2A receptor antagonist and μ-opioid receptor partial agonist, provides potential utility in the treatment of opioid use disorder and pain. A multiple ascending dose study and a positron emission tomography (PET) study are both ongoing. ITI-1500 Non-Hallucinogenic Psychedelic Program: In 2023, we introduced the ITI-1500 program. This program is focused on the development of novel non-hallucinogenic psychedelics for the treatment of mood, anxiety and other neuropsychiatric disorders without the liabilities of known psychedelics, including the hallucinogenic potential and risk for cardiac valvular pathologies. Our lead product candidate in this program, ITI-1549, is advancing through IND enabling studies and is expected to enter human testing in late 2024 or early 2025. 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. To attend the live conference call by phone, please use this registration link (https://register.vevent.com/register/BI4a916e3aa80448ae8e675216382f1cf2). All participants must use the link to complete the online registration process in advance of the conference call. The live and archived webcast can be accessed under "Events & Presentations" in the Investors 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. CAPLYTA® (lumateperone) is indicated in adults for the treatment of schizophrenia and for the treatment of depressive episodes associated with bipolar I or II disorder (bipolar depression) as monotherapy and as adjunctive therapy with lithium or valproate. Important Safety Information Boxed Warnings: 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.Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adults in short-term studies. All antidepressant-treated patients should be closely monitored for clinical worsening, and for emergence of suicidal thoughts and behaviors. The safety and effectiveness of CAPLYTA have not been established in pediatric patients. 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.Potential for Cognitive and Motor Impairment. 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. Dose reduction is recommended for concomitant use with strong CYP3A4 inhibitors or moderate CYP3A4 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. Dose reduction is recommended for patients with moderate or severe hepatic impairment. Adverse Reactions: The most common adverse reactions in clinical trials with CAPLYTA vs. placebo were somnolence/sedation, dizziness, nausea, and dry mouth. CAPLYTA is available in 10.5 mg, 21 mg, and 42 mg capsules. Please click here to see full Prescribing Information including Boxed Warning. About CAPLYTA (lumateperone) CAPLYTA 42 mg is an oral, once daily atypical antipsychotic approved in adults for the treatment of schizophrenia and the treatment of depressive episodes associated with bipolar I or II disorder (bipolar depression) as monotherapy and as adjunctive therapy with lithium or valproate. While the mechanism of action of CAPLYTA 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 studied for the treatment of major depressive disorder, 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, our financial and operating performance, including our future revenues and expenses; our expectations regarding the commercialization of CAPLYTA; our plans to conduct clinical or non-clinical trials and the timing of developments with respect to those trials, including enrollment, initiation or completion of clinical conduct, or the availability of results; plans to make regulatory submissions to the FDA and the timing of such submissions; whether clinical trial results will be predictive of future real-world results; whether CAPLYTA will serve an unmet need; the goals of our development programs; 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; whether CAPLYTA receives adequate reimbursement from third-party payors; the degree to which CAPLYTA receives acceptance from patients and physicians for its approved indications; 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 and bipolar depression following commercial launch of the product may be different than observed in clinical trials, and may vary among patients; challenges associated with supply and manufacturing activities, which in each case could limit our sales and the availability of our product; 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 bipolar depression 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; impacts on our business, including on the commercialization of CAPLYTA and our clinical trials, as a result of the COVID-19 pandemic, the conflicts in Ukraine and the Middle East, global economic uncertainty, inflation, higher interest rates or market disruptions; 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 Relations646-440-9333 Burns McClellan, Inc.Cameron Radinoviccradinovic@burnsmc.com212-213-0006 INTRA-CELLULAR THERAPIES, INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (in thousands except share and per share amounts) (Unaudited) (1) Three Months Ended December 31, Twelve Months Ended December 31, 2023 2022 2023 2022 Revenues Product sales, net$131,506 $87,433 $462,175 $249,132 Grant revenue 593 436 2,195 1,182 Total revenues, net 132,099 87,869 464,370 250,314 Operating expenses: Cost of product sales 10,702 6,788 33,745 20,443 Selling, general and administrative 104,720 94,631 409,864 358,782 Research and development 50,774 33,862 180,142 134,715 Total operating expenses 166,196 135,281 623,751 513,940 Loss from operations (34,097) (47,412) (159,381) (263,626)Interest income 5,966 3,386 20,343 7,376 Loss before provision for income taxes (28,131) (44,026) (139,038) (256,250)Income tax expense (448) — (636) (6)Net loss$(28,579) $(44,026) $(139,674) $(256,256)Net loss per common share: Basic & Diluted$(0.30) $(0.45) $(1.46) $(2.72)Weighted average number of common shares: Basic & Diluted 96,285,558 94,516,794 95,881,729 94,046,670 (1) The condensed consolidated statements of operations for the three and twelve months ended December 31, 2023 and 2022 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(in thousands except share and per share amounts) (Unaudited) December 31,2023 December 31,2022Assets Current assets: Cash and cash equivalents$147,767 $148,615 Investment securities, available-for-sale 350,174 443,290 Restricted cash 1,750 1,750 Accounts receivable, net 114,018 75,189 Inventory 11,647 23,920 Prepaid expenses and other current assets 42,443 45,193 Total current assets 667,799 737,957 Property and equipment, net 1,654 1,913 Right of use assets, net 12,928 14,824 Inventory, non-current 38,621 — Other assets 7,293 86 Total assets$728,295 $754,780 Liabilities and stockholders’ equity Current liabilities: Accounts payable$11,452 $10,395 Accrued and other current liabilities 27,944 19,657 Accrued customer programs 53,173 25,621 Accrued employee benefits 27,364 22,996 Operating lease liabilities 3,612 4,567 Total current liabilities 123,545 83,236 Operating lease liabilities, non-current 13,326 15,474 Total liabilities 136,871 98,710 Stockholders’ equity: Common stock, $0.0001 par value: 175,000,000 shares authorized at December 31, 2023 and December 31, 2022, respectively; 96,379,811 and 94,829,794 shares issued and outstanding at December 31, 2023 and December 31, 2022, respectively 10 9 Additional paid-in capital 2,208,470 2,137,737 Accumulated deficit (1,617,160) (1,477,486)Accumulated comprehensive income (loss) 104 (4,190)Total stockholders’ equity 591,424 656,070 Total liabilities and stockholders’ equity$728,295 $754,780 The condensed consolidated balance sheets at December 31, 2023 and December 31, 2022 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.

— Results Demonstrated that LYBALVI was Generally Well Tolerated With Stability of Body Weight and Metabolic Profile, and Durable Symptom Control, for Up to Four Years of Treatment — DUBLIN, Jan. 3, 2024 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) today announced topline results from a phase 3, open-label extension study assessing the long-term safety, tolerability and durability of treatment effect of LYBALVI® (olanzapine and samidorphan) in patients with schizophrenia, schizophreniform disorder or bipolar I disorder for up to four years of treatment, following treatment received in prior LYBALVI studies. LYBALVI is approved in the U.S. for the treatment of adults with schizophrenia, and for the treatment of adults with bipolar I disorder, as a maintenance monotherapy or for the acute treatment of manic or mixed episodes, as monotherapy or as adjunct to lithium or valproate. In this global, open-label extension study, 523 participants received at least one dose of LYBALVI and 35.9% of participants completed the four-year treatment period. The safety profile of LYBALVI was consistent with previous studies. Patients' symptoms of schizophrenia or bipolar I disorder remained stable with up to four years of treatment with LYBALVI, as measured by the Clinical Global Impression of Severity (CGI-S) scale (mean change from baseline in CGI-S score of -0.28). Long-term treatment with LYBALVI was associated with minimal changes in body weight (mean change from baseline of +1.47 kg) and waist circumference (observed mean change from baseline of +0.61 cm) with up to four years of treatment. Similarly, there were generally minimal changes in lipid and glycemic parameters, including HDL cholesterol, LDL cholesterol, triglycerides, fasting glucose and HbA1c over the measured time period. Overall, 60% of patients reported an adverse event (AE). The most common AEs reported (>5%) were weight gain, headache, anxiety, insomnia, somnolence, nausea and weight decrease; most AEs were mild to moderate in severity. "As clinicians, we see firsthand the challenges that people living with complex mental health conditions may face in finding treatment options that work for them long term, in terms of both efficacy and tolerability," said Jacob S. Ballon, M.D., M.P.H., Clinical Professor of Psychiatry and Behavioral Sciences at Stanford University and a study investigator. "These data, which demonstrated long-term tolerability and symptom control, as well as stability across key weight and metabolic factors, underscore LYBALVI's established safety and efficacy profile and provide important information for clinicians as we navigate treatment decisions with our patients in the real world." "We are pleased to share the topline results from this long-term, open-label study. These data highlight the potential utility of LYBALVI as a foundational maintenance treatment option for people living with schizophrenia or bipolar I disorder and reinforce the safety profile of LYBALVI established in previous studies," said Craig Hopkinson, M.D., Executive Vice President, Research & Development and Chief Medical Officer at Alkermes. "In this study, patients taking LYBALVI experienced sustained treatment effect and tolerability, including stability across multiple metabolic parameters. Against the backdrop of average treatment persistency of less than six months for oral atypical antipsychotics generally, we are encouraged that more than one-third of subjects completed four years of treatment with LYBALVI." Alkermes expects to submit results from this open-label, long-term study to a peer-reviewed journal for publication and to present additional study results at upcoming scientific meetings. Phase 3, Open-Label Study Design This was a multicenter, phase 3, open-label extension study assessing the long-term safety, tolerability and durability of treatment effect of LYBALVI for up to four years. Patients were eligible to enroll within seven days of completing one of three antecedent phase 3 clinical trials investigating LYBALVI: the ENLIGHTEN-1 safety extension study; the ENLIGHTEN-2 safety extension study (rollover extensions of the ENLIGHTEN-1 and ENLIGHTEN-2 phase 3 pivotal randomized controlled trials in adults with schizophrenia); and the 12-week ENLIGHTEN-Early randomized controlled trial comparing LYBALVI to olanzapine in young adults with recent-onset schizophrenia, schizophreniform disorder, or bipolar I disorder. In this long-term extension study, patients continued their daily dose of LYBALVI (olanzapine 5-20 mg + samidorphan 10 mg) from their antecedent study for up to an additional four years, with dose adjustments determined by the investigator. A total of 524 patients enrolled in the study, and 523 received ≥1 dose of LYBALVI. Baseline was established based on these 523 patients and changes as compared to baseline were based on those patients who completed four years of open-label treatment with LYBALVI. Patients were mostly male (61.6%) and White (72.7%), with a mean age of 35.1 years. Safety assessments included changes from baseline in body weight and waist circumference and the incidence of adverse events (AEs). Changes in lipid (high-density lipoprotein [HDL], low-density lipoprotein [LDL], and total cholesterol and triglycerides) and glycemic (glucose and glycosylated hemoglobin [HbA1c]) parameters were evaluated. Antipsychotic efficacy was assessed using the Clinical Global Impressions–Severity (CGI-S) scale. About Schizophrenia and Schizophreniform Disorder Schizophrenia is a serious brain disorder marked by positive symptoms (hallucinations and delusions, disorganized speech and thoughts, and agitated or repeated movements) and negative symptoms (depression, blunted emotions and social withdrawal).1 Schizophrenia affects approximately 1.1% of the U.S. population.2 Schizophreniform disorder exhibits symptoms similar to schizophrenia, but without sufficient duration for a diagnosis of schizophrenia (one to six months).1 About Bipolar I Disorder Bipolar disorder is a brain disorder that is marked by extreme changes in a person's mood, energy and ability to function. Individuals with this brain disorder may experience debilitating mood states, including extreme highs (mania) and extreme lows (depression). Bipolar I disorder is characterized by the occurrence of at least one manic episode, with or without the occurrence of a major depressive episode, and affects approximately 1% of the adult population in the United States in any given year.3 About LYBALVI® (olanzapine and samidorphan) LYBALVI ® (olanzapine and samidorphan) is a once-daily, oral atypical antipsychotic drug approved in the U.S. for the treatment of adults with schizophrenia and for the treatment of adults with bipolar I disorder, as a maintenance monotherapy or for the acute treatment of manic or mixed episodes, as monotherapy or an adjunct to lithium or valproate. LYBALVI is a combination of olanzapine, an atypical antipsychotic, and samidorphan, an opioid antagonist, in a single bilayer tablet. LYBALVI is available in fixed dosage strengths composed of 10 mg of samidorphan and 5 mg, 10 mg, 15 mg or 20 mg of olanzapine. IMPORTANT SAFETY INFORMATION for LYBALVI® (olanzapine and samidorphan) Boxed Warning: Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. LYBALVI is not approved for the treatment of patients with dementia-related psychosis. Contraindications: LYBALVI is contraindicated in patients who are using opioids or are undergoing acute opioid withdrawal. If LYBALVI is administered with lithium or valproate, refer to the lithium or valproate Prescribing Information for the contraindications for these products. Cerebrovascular Adverse Reactions in Elderly Patients with Dementia-Related Psychosis, including stroke, transient ischemia attack, and fatalities. See Boxed Warning above. Precipitation of Severe Opioid Withdrawal in Patients who are Physiologically Dependent on Opioids: LYBALVI can precipitate opioid withdrawal in patients who are dependent on opioids, which can lead to an opioid withdrawal syndrome, sometimes requiring hospitalization. LYBALVI is contraindicated in patients who are using opioids or undergoing acute opioid withdrawal. Prior to initiating LYBALVI, there should be at least a 7-day opioid-free interval from last use of short-acting opioids, and at least a 14-day opioid-free interval from the last use of long-acting opioids. Explain the risks associated with precipitated withdrawal and the importance of giving an accurate account of last opioid use to patients and caregivers. Vulnerability to Life-Threatening Opioid Overdose: Attempting to overcome opioid blockade with high or repeated doses of exogenous opioids could lead to life-threatening or fatal opioid intoxication, particularly if LYBALVI therapy is interrupted or discontinued subjecting the patient to high levels of unopposed opioid agonist as the samidorphan blockade wanes. Inform patients of the potential consequences of trying to overcome the opioid blockade and the serious risks of taking opioids concurrently with LYBALVI or while transitioning off LYBALVI. In emergency situations, if a LYBALVI-treated patient requires opioid treatment as part of anesthesia or analgesia, discontinue LYBALVI. Opioids should be administered by properly trained individual(s) and patient should be continuously monitored in a setting equipped and staffed for cardiopulmonary resuscitation. Patients with a history of chronic opioid use prior to treatment with LYBALVI may have decreased opioid tolerance if LYBALVI therapy is interrupted or discontinued. Advise patients that this decreased tolerance may increase the risk of opioid overdose if opioids are resumed at the previously tolerated dosage. Neuroleptic Malignant Syndrome, 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, intensive symptomatic treatment, and close monitoring. Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), a potentially fatal condition reported with exposure to olanzapine, a component of LYBALVI. Symptoms include a cutaneous reaction (such as rash or exfoliative dermatitis), eosinophilia, fever, and/or lymphadenopathy with systemic complications such as hepatitis, nephritis, pneumonitis, myocarditis, and/or pericarditis. Discontinue if DRESS is suspected. Metabolic Changes, including hyperglycemia, diabetes mellitus, dyslipidemia, and weight gain. Hyperglycemia, in some cases extreme and associated with ketoacidosis or hyperosmolar coma or death, has been reported in patients treated with atypical antipsychotics. Any patient treated with LYBALVI should be monitored for symptoms of hyperglycemia including polydipsia, polyuria, polyphagia, and weakness. In some cases, hyperglycemia has resolved when the atypical antipsychotic was discontinued; however, some patients required anti-diabetic treatment despite discontinuation of the suspect drug. Measure weight and assess fasting glucose and lipids when initiating LYBALVI and monitor periodically. Tardive Dyskinesia (TD): Risk of developing TD (a syndrome of potentially irreversible, involuntary, dyskinetic movements) and the likelihood it will become irreversible increases with the duration of treatment and the cumulative dose. The syndrome can develop after a relatively brief treatment period, even at low doses, or after discontinuation. Given these considerations, LYBALVI should be prescribed in a manner that is most likely to reduce the risk of tardive dyskinesia. If signs and symptoms of TD appear, drug discontinuation should be considered. Orthostatic Hypotension and Syncope: Monitor orthostatic vital signs in patients who are vulnerable to hypotension, patients with known cardiovascular disease, and patients with cerebrovascular disease. Falls: LYBALVI may cause somnolence, postural hypotension, and motor and sensory instability, which may lead to falls, and consequently, fractures or other injuries. Assess patients for risk when using LYBALVI. Leukopenia, Neutropenia, and Agranulocytosis (including fatal cases): Perform complete blood counts in patients with a history of a clinically significant low white blood cell (WBC) count or history of leukopenia or neutropenia. Discontinue LYBALVI if clinically significant decline in WBC occurs in the absence of other causative factors. Dysphagia: Use LYBALVI with caution in patients at risk for aspiration. Seizures: Use LYBALVI with caution in patients with a history of seizures or with conditions that lower the seizure threshold. Potential for Cognitive and Motor Impairment: Because LYBALVI may cause somnolence, impair judgment, thinking, or motor skills, caution patients about operating hazardous machinery, including motor vehicles, until they are certain that LYBALVI does not affect them adversely. Body Temperature Dysregulation: Use LYBALVI with caution in patients who may experience conditions that increase core body temperature (e.g., strenuous exercise, extreme heat, dehydration, or concomitant use with anticholinergics). Anticholinergic (Antimuscarinic) Effects: Olanzapine, a component of LYBALVI, was associated with constipation, dry mouth, and tachycardia. Use LYBALVI with caution with other anticholinergic medications and in patients with urinary retention, prostatic hypertrophy, constipation, paralytic ileus or related conditions. In postmarketing experience, the risk for severe adverse reactions (including fatalities) was increased with concomitant use of anticholinergic medications. Hyperprolactinemia: LYBALVI elevates prolactin levels. Galactorrhea, amenorrhea, gynecomastia, and impotence have been reported in patients receiving prolactin-elevating compounds. Risks Associated with Combination Treatment with Lithium or Valproate: If LYBALVI is administered with lithium or valproate, refer to the lithium or valproate Prescribing Information for a description of the risks for these products. Most common adverse reactions observed in clinical trials were: Schizophrenia (LYBALVI): weight increased, somnolence, dry mouth, and headache Bipolar I Disorder, Manic or Mixed Episodes (olanzapine): asthenia, dry mouth, constipation, increased appetite, somnolence, dizziness, tremor Bipolar I Disorder, Manic or Mixed Episodes, adjunct to Lithium or Valproate (olanzapine): dry mouth, dyspepsia, weight gain, increased appetite, dizziness, back pain, constipation, speech disorder, increased salivation, amnesia, paresthesia Concomitant Medication: LYBALVI is contraindicated in patients who are using opioids or undergoing acute opioid withdrawal. Concomitant use of LYBALVI is not recommended with strong CYP3A4 inducers, levodopa and dopamine agonists. Reduce dosage of LYBALVI when using with strong CYP1A2 inhibitors. Increase dosage of LYBALVI with CYP1A2 inducers. Use caution with diazepam, alcohol, other CNS acting drugs, or in patients receiving anticholinergic (antimuscarinic) medications. Monitor blood pressure and reduce dosage of antihypertensive drug in accordance with its approved product labeling. Pregnancy: May cause extrapyramidal and/or withdrawal symptoms in neonates with third trimester exposure. Advise patients to notify their healthcare provider if they become pregnant or intend to become pregnant during treatment with LYBALVI. Inform patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to LYBALVI during pregnancy. Renal Impairment: LYBALVI is not recommended for patients with end-stage renal disease (eGFR of <15 mL/minute/1.73 m2). To report SUSPECTED ADVERSE REACTIONS, contact Alkermes at 1-888-235-8008 or FDA at 1-800-FDA-1088 or . Please see full Prescribing Information, including Boxed Warning, for LYBALVI. About Alkermes plc Alkermes plc is a global biopharmaceutical company that seeks to develop innovative medicines in the field of neuroscience. The company has a portfolio of proprietary commercial products for the treatment of alcohol dependence, opioid dependence, schizophrenia and bipolar I disorder and a pipeline of clinical and preclinical candidates in development for neurological disorders. Headquartered in Dublin, Ireland, Alkermes has a research and development center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio. For more information, please visit Alkermes' website at . Note Regarding Forward-Looking Statements Certain statements set forth in this press release constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, but not limited to, statements concerning the potential therapeutic and commercial value of LYBALVI for people living with schizophrenia or bipolar I disorder. The company cautions that forward-looking statements are inherently uncertain. Although the company believes that such statements are based on reasonable assumptions within the bounds of its knowledge of its business and operations, the forward-looking statements are neither promises nor guarantees and they are necessarily subject to a high degree of uncertainty and risk. Actual performance and results may differ materially from those expressed or implied in the forward-looking statements due to various risks and uncertainties. These risks and uncertainties include, among others: whether clinical results for LYBALVI will be predictive of future clinical results or real-world results; whether LYBALVI could be shown to be ineffective or unsafe; and those risks and uncertainties described under the heading "Risk Factors" in the company's Annual Report on Form 10-K for the year ended Dec. 31, 2022 and in subsequent filings made by the company with the U.S. Securities and Exchange Commission ("SEC"), which are available on the SEC's website at . Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Except as required by law, the company disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release. LYBALVI ® is a registered trademark of Alkermes Pharma Ireland Limited, used by Alkermes, Inc. under license. References 1 American Psychiatric Association. Schizophrenia Spectrum and Other Psychiatric Disorders. Diagnostic and Statistical Manual of Mental Disorders. 5th ed. Washington, DC: American Psychiatric Publishing; 2013. 2 Cloutier M. Journal of Clinical Psychiatry. 2016 Jun; 77(6): 764-71. 3 Merikangas et al. Lifetime and 12-Month Prevalence of Bipolar Spectrum Disorder in the National Comorbidity Survey Replication. Arch Gen Psychiatry, 2007 May; 64(5): 543-552. SOURCE Alkermes plc

Company presents positive results of a pre-specified patient population in Study 403 examining the effects of CAPLYTA® (lumateperone) in patients experiencing a major depressive episode with anxious distress and mixed features. Company presents preclinical data on ITI-1549, our lead product candidate in our non-hallucinogenic psychedelics program in mood disorders and other psychiatric disorders. NEW YORK, Dec. 05, 2023 (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 data presentations at the American College of Neuropsychopharmacology (ACNP) 62nd Annual Meeting. “We are pleased to present new analyses at ACNP showing the antidepressant effects of lumateperone in patients with anxious distress and mixed features which further strengthen our confidence in CAPLYTA’s potential as a broad treatment for MDD and other mood disorders,” said Dr. Suresh Durgam, Executive Vice President and Chief Medical Officer of Intra-Cellular Therapies. “In addition, we are excited to share preclinical data on our newly introduced non-hallucinogenic psychedelic development program.” Monday, December 4: Poster M91: “Lumateperone in the Treatment of Patients With Major Depressive Disorder and Bipolar Disorder with Anxious Distress and Mixed Features” The poster presented at ACNP reports on an important post-hoc analysis from Study 403 evaluating the antidepressant effects of lumateperone in a pre-specified subgroup of patients with mixed features exhibiting anxious distress (commonly known as anxious depression). Lumateperone improved change from baseline for MADRS total score at Day 43 compared with placebo in all three populations with anxious distress: combined major depressive disorder (MDD)/bipolar depression population (6.1 point reduction v. placebo; Cohen’s d effect size (ES) = 0.67), MDD individual population (6.8 point reduction v. placebo; ES= 0.79), and bipolar depression individual population (5.5 point reduction v. placebo; ES= 0.59). Greater improvements vs placebo in MADRS Total score occurred by Day 15 and persisted throughout the study. Similarly, in the Clinical Global Impression Scale-Severity (CGI-S) lumateperone was superior versus placebo in all three patient populations. Cohen-D effect sizes on the CGI-s ranged from 0.48 to 0.66. In DSM-5 anxious distress is defined as the presence of ≥2 anxious symptoms (feeling tense, feeling restless, difficulty concentrating, fearful something awful may happen, or feeling out of control) during the majority of days during the current or most recent major depressive episode. Using this definition, anxious distress was present in 73.9% in MDD and 54.3% in bipolar depression patients enrolled in the study, highlighting its high prevalence, consistent with the literature. Inner tension is an item within the MADRS which is often used as a surrogate marker for anxiety. With respect to the MADRS inner tension single-item score, lumateperone improved change from baseline at Day 43 compared with placebo for all three populations with anxious distress, demonstrating the consistency of the results. The data presented in this poster represent further analyses from Study 403. Study 403 evaluated lumateperone 42mg as monotherapy in the treatment of major depressive episodes in patients with MDD with mixed features and in patients with bipolar depression with mixed features. Topline results for Study 403 are shown in Poster M88 and described below. Both DSM-5 specifiers, mixed features and anxious distress, are common in patients with MDD and bipolar depression and their presence is associated with more pernicious forms of depressive illness (symptom severity, more comorbidities, increased suicide risk) and poor treatment response. In this analysis, lumateperone improved depression symptoms and severity score versus placebo in patients with MDD or bipolar depression with anxious distress and mixed features. Poster M131: “Discovery and Characterization of ITI-1549, a Novel Non-hallucinogenic Psychedelic For the Treatment of Neuropsychiatric Disorders” We are developing novel non-hallucinogenic psychedelics that allow exploration of this psychoactive drug class in neuropsychiatric conditions including mood disorders without the liabilities of known psychedelics, such as induction of hallucinations and risks for cardiac valvular pathologies. The lead molecule in this program, ITI-1549, is advancing through IND enabling studies and is expected to enter human testing in late 2024 or early 2025. This poster describes the in-vitro and in-vivo preclinical characterization of ITI-1549. In vitro, similar to known hallucinogenic psychedelics, ITI-1549 exhibits high affinity binding to 5-HT2a receptors. Functionally, ITI-1549 acts as an agonist at 5-HT2A receptors favoring postsynaptic signaling within the beta-arrestin pathway over G-protein coupled pathways. Activation of the 5-HT2a receptor coupled Gq signaling pathway has been linked to hallucinogenic properties of psychedelic compounds. By preferentially activating the beta-arrestin pathway, ITI-1549 and compounds in this chemical series may retain the beneficial therapeutic effects of psychedelics without hallucinogenic effects. Importantly, unlike most psychedelics, ITI-1549 is not a 5-HT2b agonist which has been associated with heart valve pathologies. In animal models, we have shown that ITI-1549 does not elicit head twitch behaviors in mice, which are predictive of hallucinogenic potential in humans; based on these data ITI-1549 can be classified as a non-hallucinogenic agent. ITI-1549 has also shown to increase social interaction and reduce anxiety and depressive symptoms in preclinical models. It also activates the mTOR pathway in the prefrontal cortex, which is associated with increased neuroplasticity and rapid antidepressant activity in preclinical models. In conclusion, ITI-1549 may be a safe, non-hallucinogenic psychedelic without the liability to induce hallucinations and cardiac pathologies while retaining the potential as an acute or chronic treatment of mood, anxiety and other neuropsychiatric disorders. Poster M88: “Lumateperone Treatment for Major Depressive Episodes with Mixed Features in Major Depressive Disorder and Bipolar I or Bipolar II Disorder” This poster describes further data analyses from Study 403 in mixed features. In this study, lumateperone 42mg was statistically significant on the primary endpoint of symptom reduction on the MADRS for the combined mixed features patient population of MDD and bipolar depression (5.7 point reduction v. placebo; p<0.0001; Cohen’s d effect size (ES) of 0.64) and the individual patient populations of MDD with mixed features (5.9 point reduction v. placebo; p<0.0001; ES= 0.67) and bipolar depression with mixed features (5.7 point reduction v. placebo; p<0.0001; ES= 0.64). Lumateperone 42mg also met the key secondary endpoint by demonstrating a statistically significant and clinically meaningful reduction in the Clinician’s Global Impression scale or CGI compared to placebo at Week 6 in all three patient populations. Lumateperone was generally safe and well tolerated, with a side effect profile consistent with prior lumateperone trials. The most common adverse events in the study were somnolence, dizziness and nausea. There were no notable changes in weight, body mass index, or waist circumference and no clinically relevant changes in metabolic parameters. CAPLYTA® (lumateperone) is indicated in adults for the treatment of schizophrenia and depressive episodes associated with bipolar I or II disorder (bipolar depression) as monotherapy and as adjunctive therapy with lithium or valproate. Important Safety Information Boxed Warnings: 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.Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adults in short-term studies. All antidepressant-treated patients should be closely monitored for clinical worsening, and for emergence of suicidal thoughts and behaviors. The safety and effectiveness of CAPLYTA have not been established in pediatric patients. 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.Potential for Cognitive and Motor Impairment. 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. Dose reduction is recommended for concomitant use with strong CYP3A4 inhibitors or moderate CYP3A4 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. Dose reduction is recommended for patients with moderate or severe hepatic impairment. Adverse Reactions: The most common adverse reactions in clinical trials with CAPLYTA vs. placebo were somnolence/sedation, dizziness, nausea, and dry mouth. CAPLYTA is available in 10.5 mg, 21 mg, and 42 mg capsules. Please click here to see full Prescribing Information including Boxed Warning. About CAPLYTA (lumateperone) CAPLYTA 42 mg is an oral, once daily atypical antipsychotic approved in adults for the treatment of schizophrenia and depressive episodes associated with bipolar I or II disorder (bipolar depression) as monotherapy and as adjunctive therapy with lithium or valproate. While the mechanism of action of CAPLYTA 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 studied for the treatment of major depressive disorder, 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, our plans to conduct clinical or non-clinical trials and the timing of those trials, including enrollment, initiation or completion of clinical conduct, or the availability of results; plans to make regulatory submissions to the FDA and the timing of such submissions; whether clinical trial results will be predictive of future real-world results; whether CAPLYTA will serve an unmet need; the goals of our development programs; 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; whether CAPLYTA receives adequate reimbursement from third-party payors; the degree to which CAPLYTA receives acceptance from patients and physicians for its approved indications; 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 and bipolar depression following commercial launch of the product may be different than observed in clinical trials, and may vary among patients; challenges associated with supply and manufacturing activities, which in each case could limit our sales and the availability of our product; 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 bipolar depression 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; impacts on our business, including on the commercialization of CAPLYTA and our clinical trials, as a result of the COVID-19 pandemic, the conflicts in Ukraine and the Middle East, global economic uncertainty, inflation, higher interest rates or market disruptions; 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 Relations646-440-9333 Burns McClellan, Inc.Cameron Radinoviccradinovic@burnsmc.com212-213-0006