Bipolar II disorder

Company to initiate Phase 2 trial of ABX-002 for bipolar depression by yearend 2024 ABX-002 also being evaluated as an adjunctive treatment for major depressive disorder in the ongoing AMPLIFY Phase 2 trial SAN DIEGO--(BUSINESS WIRE)--Autobahn Therapeutics, a biotechnology company developing restorative treatments for people affected by neuropsychiatric and neuroimmunologic disorders, today announced the clearance of an investigational new drug (IND) application by the U.S. Food and Drug Administration (FDA) to support initiation of a Phase 2 trial of ABX-002 as an adjunctive treatment for patients with bipolar depression. ABX-002 is a highly potent, oral, thyroid hormone beta receptor (TRβ) selective agonist designed to enhance the CNS benefits of thyroid hormone biology and drug concentrations directly in the brain. “We are thrilled to expand our depression treatment program with ABX-002 and evaluate its potential to safely address the debilitating symptoms of bipolar depression, a highly prevalent and potentially life-threatening disorder,” said Kevin Finney, Autobahn’s President and CEO. “In the U.S. alone, seven million patients suffer from bipolar disorder and there are limited safe and effective therapies that focus specifically on the depressive symptoms that patients face. Our planned Phase 2 trial is designed to provide proof-of-concept for ABX-002 and inform further clinical development in bipolar depression. With this regulatory clearance, we are excited to advance ABX-002 into a second clinical development program later this year alongside our recently initiated Phase 2 study in major depressive disorder.” The Phase 2 trial will evaluate ABX-002 as adjunctive therapy in adult patients with depressive episodes associated with bipolar I or bipolar II disorder. Autobahn will evaluate the biological and clinical proof-of-concept for ABX-002 across multiple endpoints in the trial, including changes in energy metabolism in the brain as determined by phosphorus magnetic resonance spectroscopy ( 31 P-MRS) and changes in patients’ depressive symptoms as measured by the Hamilton Depression Rating Scale (HAMD). ABX-002 is also being evaluated in the company’s ongoing AMPLIFY Phase 2 trial as an adjunctive treatment for patients with major depressive disorder (MDD), with topline data expected in the second half of 2025. About Autobahn Therapeutics Autobahn Therapeutics is a biotechnology company developing a portfolio of neuropsychiatric and neuroimmunologic clinical candidates leveraging its brain-targeting chemistry platform. Autobahn aims to unlock new therapeutic opportunities through precision tuning of CNS exposure, pursuing validated clinical and biologic targets, and guiding development with biomarkers. The company’s pipeline is led by ABX-002, a thyroid hormone receptor beta (TRβ) agonist being developed as a potential adjunctive treatment for people with major depressive disorder and bipolar disorder depression. Autobahn Therapeutics is based in San Diego. For more information, visit . About ABX-002 ABX-002 is an orally administered, potent and selective thyroid hormone beta receptor (TRβ) agonist designed to enhance the CNS benefits of thyroid hormone biology while also reducing the peripheral liabilities of synthetic thyroid hormone (e.g., triiodothyronine, T3), a treatment which has shown efficacy in numerous placebo-controlled human studies across MDD and bipolar depression. Thyroid hormone agonism has demonstrated activity on cellular energy metabolism pathways, which play an important role on the regulation of brain bioenergetics and may be uniquely suited to address symptoms of atypical depression, a highly prevalent and underserved sub-population of MDD. In nonclinical and clinical studies, ABX-002 has demonstrated optimized PK properties, target engagement in brain regions associated with depression, and an attractive safety and tolerability profile. Contacts Investors: Alex Straus THRUST Strategic Communications alex@thrustsc.com Media: Ryan Flinn In Like Flinn Communications ryan@inlikeflinncommunications.com

Phase 2a efficacy and safety trial enrollment initiation expected in H1 2025 ~40 million Americans go to emergency department annually after a traumatic experience 1 Second externally funded stress-related trial for BXCL501 NEW HAVEN, Conn., Oct. 15, 2024 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience, today announced a collaboration with the University of North Carolina at Chapel Hill (UNC) on a grant awarded by the U.S. Department of Defense (DoD) to evaluate the efficacy and safety of BXCL501 as a potential treatment for acute stress disorder (ASD). The award provides $2.8 million to the UNC Institute for Trauma Recovery from September 15, 2024 through September 14, 2026 to evaluate the potential efficacy of BXCL501 to reduce ASD symptom severity and/or posttraumatic neuropsychiatric symptoms. The double-blind, placebo-controlled trial is expected to enroll 100 patients experiencing ASD resulting from motor vehicle collisions, beginning in the first half of 2025. BioXcel Therapeutics will supply BXCL501 for the trial. ASD symptoms occur in the days and weeks after trauma, and include anxiety, sleep disturbance, concentration difficulty, pain, and somatic symptoms such as dizziness and lightheadedness. Chronic adverse posttraumatic neuropsychiatric symptoms occur when acute stress reaction does not resolve, and include persistent pain, posttraumatic stress, and depressive symptoms. ASD prevalence varies considerably based on the study and nature of the trauma. An estimated 40 million Americans annually go to the emergency department after a traumatic experience.1 “There is an urgent need for effective interventions to prevent the development of these ‘invisible wounds,’” said Principal Investigator Samuel McLean, M.D., MPH, Professor of Psychiatry and Emergency Medicine and Director of the Institute for Trauma Recovery at the UNC School of Medicine. “Fortunately, advances in research methods and biologic understanding have created an opportunity to develop interventions to prevent symptoms associated with ASD. We look forward to initiating this important study of BXCL501, which could potentially be administered to patients in the early aftermath of severe trauma to reduce acute stress symptoms and prevent the emergence of chronic symptoms.” “In addition to our development of PRN dosing treatment with BXCL501 for agitation associated with bipolar disorders, schizophrenia, and Alzheimer’s dementia, BXCL501 may have potential as a precision medicine for short-term treatment of the spectrum of symptoms related to trauma and stress-related disorders,” said Frank Yocca, Ph.D., Chief Scientific Officer of BioXcel Therapeutics. “Our lead neuroscience asset is currently being evaluated by Yale University School of Medicine for the potential short-term treatment of PTSD related to alcohol and substance abuse disorder, and we are pleased that a second externally funded trial will soon commence led by another prominent academic research institution.” The ASD research is supported by the DoD under award number HT9425-24-1-1108. The content presented in this release is solely the responsibility of the authors and does not necessarily represent the official views of the DoD. About BXCL501 Government-Supported Investigator-Initiated Trials In addition to Acute Stress Disorder (ASD), BioXcel Therapeutics has been awarded grant programs for the development of BXCL501 for the potential treatment of post-traumatic stress disorder (PTSD)/alcohol use disorder (AUD) and opioid use disorder (OUD). A PTSD/AUD outpatient trial is being led by clinical researchers and regulatory staff at Yale University Medical School and funded through a cooperative agreement with the DoD’s Pharmacotherapies for Alcohol and Substance Use Disorders Alliance. An OUD inpatient trial is being led by clinical researchers and regulatory staff at Columbia University and funded through a cooperative agreement with the National Institute on Drug Abuse (NIDA). About BXCL501Outside of its approved indication by the U.S. Food and Drug Administration as IGALMI™ (dexmedetomidine) sublingual film, BXCL501 is an investigational proprietary, orally dissolving film formulation of dexmedetomidine, a selective alpha-2 adrenergic receptor agonist. BXCL501 is under investigation by BioXcel Therapeutics for the acute treatment of agitation associated with bipolar I or II disorder or schizophrenia in the at-home setting and for the acute treatment of agitation associated with Alzheimer’s dementia. The safety and efficacy of BXCL501 for these investigational uses have not been established. BXCL501 has been granted Breakthrough Therapy designation by the FDA for the acute treatment of agitation associated with dementia and Fast Track designation for the acute treatment of agitation associated with schizophrenia, bipolar disorders, and dementia. About BioXcel Therapeutics, Inc.BioXcel Therapeutics, Inc. (Nasdaq: BTAI) is a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience. Its wholly owned subsidiary, OnkosXcel Therapeutics, is focused on the development of medicines in immuno-oncology. The Company’s drug re-innovation approach leverages existing approved drugs and/or clinically validated product candidates together with big data and proprietary machine learning algorithms to identify new therapeutic indications. For more information, please visit bioxceltherapeutics.com. Forward-Looking Statements This press release includes “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. We intend such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act of 1933, as amended and Section 21E of the Securities Exchange Act of 1934, as amended. All statements contained in this press release other than statements of historical fact should be considered forward-looking statements, including, without limitation, statements related to: the expected funding, timing and outcome of trial of BXCL501 evaluating its ability to potentially treat agitation resulting from acute stress disorder. When used herein, words including “anticipate,” “believe,” “can,” “continue,” “could,” “designed,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, though not all forward-looking statements use these words or expressions. In addition, any statements or information that refer to expectations, beliefs, plans, projections, objectives, performance or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking. All forward-looking statements are based upon the Company’s current expectations and various assumptions. The Company believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. The Company may not realize its expectations, and its beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various important factors, including, without limitation: its limited operating history; its incurrence of significant losses; its need for substantial additional funding and ability to raise capital when needed; the impact of the reprioritization; its significant indebtedness, ability to comply with covenant obligations and potential payment obligations related to such indebtedness and other contractual obligations; the Company has identified conditions and events that raise substantial doubt about its ability to continue as a going concern; its limited experience in drug discovery and drug development; risks related to the TRANQUILITY program; its dependence on the success and commercialization of IGALMI™, BXCL501, BXCL502, BXCL701 and BXCL702 and other product candidates; the number of episodes of agitation and the size of the Company’s total addressable market may be overestimated, and approval that the Company may obtain may be based on a narrower definition of the patient population; its lack of experience in marketing and selling drug products; the risk that IGALMI or the Company’s product candidates may not be accepted by physicians or the medical community in general; the Company still faces extensive and ongoing regulatory requirements and obligations for IGALMI; the failure of preliminary data from its clinical studies to predict final study results; failure of its early clinical studies or preclinical studies to predict future clinical studies; its ability to receive regulatory approval for its product candidates; its ability to enroll patients in its clinical trials; undesirable side effects caused by the Company’s product candidates; its novel approach to the discovery and development of product candidates based on EvolverAI; the significant influence of and dependence on BioXcel LLC; its exposure to patent infringement lawsuits; its reliance on third parties; its ability to remain listed on the Nasdaq Capital Market and impacts from any potential delisting on the Company and its ability to raise capital; its ability to comply with the extensive regulations applicable to it; impacts from data breaches or cyber-attacks, if any; risks associated with the increased scrutiny relating to environmental, social and governance (ESG) matters; risks associated with federal, state or foreign health care “fraud and abuse” laws; and its ability to commercialize its product candidates, as well as the important factors discussed under the caption “Risk Factors” in its Annual Report on Form 10-K for the fiscal year ended December 31, 2023, as such factors may be updated from time to time in its other filings with the SEC, including without limitation its Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2024, which are accessible on the SEC’s website at www.sec.gov. These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. While the Company may elect to update such forward-looking statements at some point in the future, except as required by law, it disclaims any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing the Company’s views as of any date subsequent to the date of this press release. Contact Information Corporate/InvestorsBioXcel TherapeuticsErik Kopp 1.203.494.7062 MediaRusso PartnersDavid Schull 1.858.717.2310 Source: BioXcel Therapeutics, Inc. References Kessler, R.C., Ressler, K.J., House, S.L. et al. Socio-demographic and trauma-related predictors of PTSD within 8 weeks of a motor vehicle collision in the AURORA study. Mol Psychiatry 26, 3108–3121 (2021). https://doi.org/10.1038/s41380-020-00911-3

Oral and poster presentations of results from Study 501 evaluating lumateperone 42 mg as an adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) Poster presentations of post-hoc analyses from Study 403 including the prespecified patient population with MDD or bipolar depression with mixed features who also had anxious distress NEW YORK, Sept. 23, 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 presentations of lumateperone including the results from Phase 3 adjunctive Major Depressive Disorder (MDD), Study 501 at the 37th European College of Neuropsychopharmacology (ECNP) Congress being held September 21 - 24, 2024 in Milan, Italy. “We are very pleased to present additional lumateperone data across depressive disorders including remarkable positive results from Study 501 evaluating lumateperone 42 mg as an adjunctive therapy to antidepressants for the treatment of MDD at ECNP. The robust efficacy demonstrated by lumateperone, coupled with its favorable safety and tolerability profile, position CAPLYTA to become an important medicine for the treatment of MDD,” said Dr. Suresh Durgam, Executive Vice President and Chief Medical Officer of Intra-Cellular Therapies. “We are on track to submit our lumateperone sNDA for the adjunctive treatment of MDD including the results of Studies 501 and 502 later this year.” Details of the presentations are as follows: Study 501 Presentations Oral presentation: “Adjunctive Lumateperone Significantly Improves Symptoms of Major Depressive Disorder: Topline Results From a Randomised, Double-Blind, Placebo-Controlled Phase 3 Trial.” Monday, September 23, 15:00 - 16:20 CEST. P2127: “Lumateperone as Adjunctive Therapy in Patients With Major Depressive Disorder: Results From a Randomised, Double-blind, Phase 3 Trial.” Monday, September 23 12:35 - 14:00 CEST. Study 403 Presentations P2113: “Lumateperone in the Treatment of Patients With Major Depressive Disorder and Bipolar Disorder With Anxious Distress and Mixed Features.” Monday, September 23 12:35 - 14:00 CEST. P2096: “Lumateperone in the Treatment of Major Depressive Disorder and Bipolar Depression With Mixed Features: Efficacy Across Symptoms.” Monday, September 23 12:35 - 14:00 CEST. In Study 501, lumateperone met the primary endpoint of change from baseline at Week 6 on the Montgomery Asberg Depression Rating Scale (MADRS) total score versus placebo with a 4.9-point reduction (p<0.0001; Cohen’s d effect size (ES)= 0.61). Statistically significant reductions in depressive symptoms as measured by the MADRS were seen at the earliest time point tested, Week 1, and these improvements continued throughout the course of the trial. Lumateperone also met the key secondary endpoint of change from baseline on the clinician-rated Clinical Global Impression Scale for Severity of Illness (CGI-S) (p < 0.0001; ES: 0.67). On a patient-reported measure, the Quick Inventory of Depressive Symptomatology Self Report scale (QIDS), patients reported robust reduction in their depressive symptoms (p <0.0001). Adverse events were similar to those seen in prior studies of lumateperone as a treatment for bipolar depression and schizophrenia. Mean changes in key metabolic parameters including glucose, insulin, triglycerides, and total, LDL and HDL cholesterol were similar between lumateperone and placebo. Importantly, mean changes in weight were also similar to placebo. In an additional, similarly-designed trial, Study 502, lumateperone 42 mg plus an antidepressant met primary and key secondary efficacy endpoints (MADRS Total Score [LSMD vs placebo=−4.5; ES= 0.56; P<0.0001] and CGI-S score [LSMD vs placebo=−0.5; ES= 0.51; P<0.0001]) and was generally safe and well tolerated in patients with MDD with inadequate antidepressant response. Details of Study 502 will be presented at upcoming conferences. Study 403 presentations highlight important analyses of lumateperone’s double-blind placebo-controlled study in patients with either MDD or bipolar depression exhibiting mixed features. Poster #2113 presents a post-hoc analysis of Study 403 evaluating lumateperone’s efficacy in the prespecified patient population with MDD or bipolar depression with mixed features who also met the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) criteria for anxious distress. In this analysis, lumateperone significantly improved depression symptoms and severity (MADRS Total score and CGI-S score) compared with placebo. Lumateperone also significantly improved MADRS inner tension single-item score in patients with co-morbid anxious distress. Both anxious distress and mixed features are specified in the DSM-5 and are common in patients with major depressive episodes associated with MDD and bipolar disorder. Patients with these specifiers have more severe symptoms, more comorbidities, increased suicide risk, and/or poorer treatment response than patients without these specifiers. Poster #2096 presents a post-hoc analysis of Study 403 individual MADRS items. Treatment with lumateperone significantly improved a broad range of depression symptoms across individual MADRS items. About Major Depressive Disorder Major Depressive Disorder (MDD) is a common mood disorder in the U.S. affecting an estimated 21 million adults each year. Depressive disorders are the number two cause of years lived with disability in the world. Symptoms include sadness, hopelessness, helplessness, feelings of guilt, irritability, loss of interest in formerly pleasurable activities, cognitive impairment, disturbed sleep patterns, and suicide ideation or behavior. MDD can cause severe functional impairment, adversely affecting interpersonal relationships, and may impact quality of life. Approximately two-thirds of patients with depression fail to achieve remission with first-line treatment. 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 psychiatric 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 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 or reporting 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; there is no guarantee that a generic equivalent of CAPLYTA will not be approved and enter the market before the expiration of our patents; there is no guarantee that our planned sNDA for the treatment of MDD will be submitted or approved, if at all, on the timeline that we expect; 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, Russia 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.com646-930-4406