 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 CAPLYTAs 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 teams 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 LYTAlinkTM 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 MontgomeryÅsberg 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 12 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 RD 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 SGA 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 DetailsThe Company will host a live conference call and webcast today at 8:30 AM Eastern Time to discuss the Companys financial results and provide a corporate update. The live webcast and subsequent replay may be accessed by visiting the Companys website at Please connect to the Companys 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.CAPLYTATM lumateperone is indicated for the treatment of schizophrenia in adults. CAPLYTA is available in 42 mg capsules.Important Safety InformationBoxed 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 andor 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. 