On May 10, 2021 Intra-Cellular Therapies, Inc. (Nasdaq: ITCI), a biopharmaceutical company focused on the development and commercialization of therapeutics for central nervous system (CNS) disorders, reported its financial results for the first quarter ended March 31, 2021 and provided a corporate update (Press release, Intra-Cellular Therapies, MAY 10, 2021, View Source [SID1234579594]).

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"The acceptance of our sNDAs by the FDA is an important step towards a potential new treatment option for patients living with bipolar depression, a condition with a limited number of approved treatments. While preparing for this significant opportunity, our team will continue to execute on our commercial objectives for CAPLYTA and advance our robust pipeline," said Dr. Sharon Mates, Chairman and CEO of Intra-Cellular Therapies.

First Quarter Financial Highlights:

Total revenues were $15.9 million for the first quarter of 2021, compared to $1.1 million of total revenues for the first quarter of 2020. Net product revenues of CAPLYTA were $15.6 million for the first quarter of 2021, compared to $0.9 million in net product revenues of CAPLYTA for the same period in 2020.
Cost of product sales were $1.5 million in the first quarter of 2021 compared to $0.1 million for the first quarter of 2020.
Research and development (R&D) expenses for the first quarter of 2021 were $15.1 million, compared to $16.0 million for the first quarter of 2020. This decrease is due primarily to a decrease in manufacturing expense and is partially offset by an increase of lumateperone clinical and non-clinical expenses.
Selling, general and administrative (SG&A) expenses were $52.6 million for the first quarter of 2021, compared to $34.1 million for the same period in 2020. This increase is primarily due to an increase in sales related labor costs and commercialization costs.
Net loss for the quarter ended March 31, 2021 was $52.7 million compared to a net loss of $47.4 million for the quarter ended March 31, 2020.
Cash, cash equivalents, restricted cash and investment securities totaled $613.4 million at March 31, 2021, compared to $658.8 million at December 31, 2020.
COMMERCIAL HIGHLIGHTS

Despite the continued impact of COVID-19 on the healthcare system during the first quarter, our commercial organization continued to effectively engage with our prescribing audience through a hybrid model of in-person and virtual interactions, enhanced by digital marketing initiatives.
First quarter CAPLYTA results reflect strong commercial execution delivering continued prescription growth, increasing total prescriptions 23% versus the fourth quarter.
CAPLYTA market access coverage is strong with greater than 95% of covered lives in both Medicare Part D and State Medicaid, the major payer channels in schizophrenia. Our LytaLink program continues to be highly competitive and effective in supporting prescribing physicians and eligible patients’ access to CAPLYTA.
CLINICAL HIGHLIGHTS

Lumateperone – Bipolar Depression Program:

The U.S. Food and Drug Administration (FDA) has accepted for review the sNDAs for lumateperone 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. The FDA has assigned a PDUFA target action date of December 17, 2021 for these applications.
At the American Psychiatric Association (APA) Annual Meeting held from May 1-3, 2021, we had several presentations describing lumateperone study results. These included results from Study ‘402, a global Phase 3 clinical trial evaluating lumateperone as adjunctive therapy to lithium or valproate in the treatment of major depressive episodes associated with bipolar I or bipolar II disorder and analyses from Study ‘404 highlighting the efficacy results of patients with bipolar depression who exhibit mixed features. Another presentation summarized the overall safety and tolerability profile of the bipolar depression monotherapy program.
Other Lumateperone Programs

Mixed Features program: Study ‘403 evaluating lumateperone 42 mg in patients with major depressive disorder (MDD) and in patients with bipolar depression who exhibit mixed features is ongoing.
Adjunctive MDD program: Clinical conduct in two studies, Studies ‘501 and ‘502, our Phase 3 clinical trials evaluating lumateperone 42 mg as an adjunctive therapy to antidepressants for the treatment of MDD is anticipated to begin later this year.
Lumateperone Long Acting Injectable (LLAI) formulation: Study ITI-007-025, a Phase 1 single ascending dose study of LLAI, a formulation designed to be administered subcutaneously and to maintain therapeutic levels of lumateperone for at least one month is ongoing. Initial results from this study are anticipated in the second half of 2021.
CAPLYTA- Schizophrenia

Announced the publication of "Safety and tolerability of lumateperone 42 mg: An open-label antipsychotic switch study in outpatients with stable schizophrenia" (Correll et al. 2021) in the journal, Schizophrenia Research.
At APA we presented analyses from Study 303, our long-term safety schizophrenia study, evaluating the antidepressant effects of CAPLYTA in patients with schizophrenia with co-morbid depression, with and without concomitant antidepressant treatments.
Other Programs

ITI-1284 program: We introduced ITI-1284 ODT-SL, a deuterated form of lumateperone, a new molecular entity formulated as an orally disintegrating tablet for sublingual administration. We plan to initiate studies evaluating ITI-1284 ODT-SL for the treatment of behavioral disturbances in patients with dementia, the treatment of dementia-related psychosis and the treatment of certain depressive disorders in the elderly.
Phosphodiesterase type I inhibitor (PDE1) program: Our PDE1 inhibitor program is focused on diseases in which the PDE1 enzyme is over-expressed and/or abnormal immune cell function contributes to disease pathology. This suggests therapeutic potential across a variety of diseases, including neurological and cardiovascular diseases, as well as cancer.
We plan to advance our lead molecule, lenrispodun (ITI-214), into a Phase 2 clinical study in Parkinson’s disease in the second half of 2021.
At the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting, we presented preclinical data supporting the potential of PDE1 inhibition to enhance the anti-tumor effects of immunotherapies by altering the tumor micro-environment. Our prior studies elucidating the neuroprotective and anti-inflammatory effects of PDE1 inhibitors in the brain by regulating microglia function (brain resident macrophage-like cells) led to our exploration of similar effects outside the brain. Therefore, we hypothesized PDE1 inhibition could result in antitumor effects by controlling similar functions of macrophages in the tumor micro-environment. Our experiments indicate PDE1 inhibition prevents the migration and accumulation of monocytes and macrophages in the tumor micro-environment and could represent a novel and broadly applicable approach to the treatment of immune responsive cancers.

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

The Company will host a live conference call and webcast today at 8:30 AM Eastern Time to discuss the Company’s financial results and provide a corporate update. The live webcast and subsequent replay may be accessed by visiting the Company’s website at www.intracellulartherapies.com. Please connect to the Company’s website at least 5-10 minutes prior to the live webcast to ensure adequate time for any necessary software download. Alternatively, please call 1-(844) 835-6563 (U.S.) or 1-(970) 315-3916 (international) to listen to the live conference call. The conference ID number for the live call is 3244409. Please dial in approximately 10 minutes prior to the call.

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

Important Safety Information

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

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

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

Cerebrovascular Adverse Reactions in Elderly Patients with Dementia-Related Psychosis, including stroke and transient ischemic attack. See Boxed Warning above.
Neuroleptic Malignant Syndrome (NMS), which is a potentially fatal reaction. Signs and symptoms include: high fever, stiff muscles, confusion, changes in breathing, heart rate, and blood pressure, elevated creatinine phosphokinase, myoglobinuria (and/or rhabdomyolysis), and acute renal failure. Patients who experience signs and symptoms of NMS should immediately contact their doctor or go to the emergency room.
Tardive Dyskinesia, a syndrome of uncontrolled body movements in the face, tongue, or other body parts, which may increase with duration of treatment and total cumulative dose. TD may not go away, even if CAPLYTA is discontinued. It can also occur after CAPLYTA is discontinued.
Metabolic Changes, including hyperglycemia, diabetes mellitus, dyslipidemia, and weight gain. Hyperglycemia, in some cases extreme and associated with ketoacidosis, hyperosmolar coma or death, has been reported in patients treated with antipsychotics. Measure weight and assess fasting plasma glucose and lipids when initiating CAPLYTA and monitor periodically during long-term treatment.
Leukopenia, Neutropenia, and Agranulocytosis (including fatal cases). Complete blood counts should be performed in patients with pre-existing low white blood cell count (WBC) or history of leukopenia or neutropenia. CAPLYTA should be discontinued if clinically significant decline in WBC occurs in absence of other causative factors.
Decreased Blood Pressure & Dizziness. Patients may feel lightheaded, dizzy or faint when they rise too quickly from a sitting or lying position (orthostatic hypotension). Heart rate and blood pressure should be monitored and patients should be warned with known cardiovascular or cerebrovascular disease. Orthostatic vital signs should be monitored in patients who are vulnerable to hypotension.
Falls. CAPLYTA may cause sleepiness or dizziness and can slow thinking and motor skills, which may lead to falls and, consequently, fractures and other injuries. Patients should be assessed for risk when using CAPLYTA.
Seizures. CAPLYTA should be used cautiously in patients with a history of seizures or with conditions that lower seizure threshold.
Sleepiness and Trouble Concentrating. Patients should use caution when operating machinery or motor vehicles until they know how CAPLYTA affects them.
Body Temperature Dysregulation. CAPLYTA should be used with caution in patients who may experience conditions that may increase core body temperature such as strenuous exercise, extreme heat, dehydration, or concomitant anticholinergics.
Dysphagia. CAPLYTA should be used with caution in patients at risk for aspiration.
Drug Interactions: CAPLYTA should not be used with CYP3A4 inducers, moderate or strong CYP3A4 inhibitors and UGT inhibitors.

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

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

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

About CAPLYTA (lumateperone)

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

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