Total revenues were $71.9 million for the third quarter of 2022, compared to $22.2 million for the third quarter of 2021. Net product revenues of CAPLYTA were $71.9 million for the third quarter of 2022, compared to $21.6 million for the same period in 2021, representing a year-over-year increase of 233% and a 30% increase over the second quarter of 2022.

Cost of product sales were $5.9 million in the third quarter of 2022, compared to $2.0 million for the third quarter of 2021.

Selling, general and administrative (SG&A) expenses were $88.4 million for the third quarter of 2022, compared to $70.5 million for the third quarter of 2021. This increase is primarily due to an increase in marketing and advertising expenses and labor related costs.

Research and development (R&D) expenses for the third quarter of 2022 were $33.3 million, compared to $27.0 million for the third quarter of 2021. This increase is due to higher lumateperone clinical trial and non-clinical related costs and an increase in non-lumateperone program costs.

Net loss for the quarter ended September 30, 2022 was $53.5 million, compared to a net loss of $76.9 million for the quarter ended September 30, 2021.

Cash, cash equivalents, restricted cash and investment securities totaled $630.5 million at September 30, 2022, compared to $413.7 million at December 31, 2021. In January 2022, the Company completed a $460.0 million public offering resulting in net proceeds to the Company of approximately $433.7 million.

Following its initial approval in schizophrenia in 2019, CAPLYTA received U.S. Food and Drug Administration (FDA) approval for bipolar depression in December 2021, becoming the first medicine approved in the U.S. for the treatment of depressive episodes associated with bipolar I or II disorder (bipolar depression) in adults as monotherapy and as adjunctive therapy with lithium or valproate.

CAPLYTA’s successful launch in bipolar depression continues. Third quarter CAPLYTA total prescriptions increased by 220% versus the third quarter of 2021. Third quarter CAPLYTA total prescriptions increased by 26% versus the second quarter of 2022.

In the third quarter we launched two new dosage strengths of CAPLYTA, 10.5 mg and 21 mg. These dosage strengths expand the patient population for CAPLYTA by providing dosage recommendations for patients taking strong or moderate CYP3A4 inhibitors and patients with moderate or severe hepatic impairment.

CAPLYTA maintained broad coverage in the Medicare Part D and Medicaid channels, with greater than 98% of lives covered and approximately 85% of lives covered in the commercial channel. Our LytaLink patient and prescriber support programs are highly effective at addressing coverage and reimbursement processes and overall patient affordability where appropriate.

Adjunctive MDD program: Studies 501 and 502 are global, double-blind placebo-controlled studies evaluating lumateperone 42 mg as adjunctive treatment to antidepressants. The primary endpoint is change from baseline on the Montgomery-Asberg Depression Rating scale (MADRS) total score at week 6. Additionally, Study 503 is an open label roll-over study to assess long-term safety in this patient population. Patient enrollment in these studies is ongoing and we expect to file a supplemental New Drug Application (sNDA) with the FDA for lumateperone as an adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) in 2024.

Mixed Features program: We have completed patient enrollment in Study 403 and expect to report topline results in the first quarter of 2023. Study 403 is a global clinical trial evaluating lumateperone 42 mg in patients with MDD and in patients with bipolar depression who exhibit mixed features. Efficacy is assessed at week 6 and there is a follow-up safety visit two weeks after the last medication dose. The primary endpoint is change from baseline versus placebo on the MADRS total score at week 6, and the key secondary endpoint is the Clinical Global Impression (CGI-S) scale.

Lumateperone Long Acting Injectable (LAI) formulation: We have completed a Phase 1 single ascending dose study with our initial formulation. This study evaluated the pharmacokinetics, safety and tolerability of lumateperone LAI in patients with stable symptoms of schizophrenia. We have also explored alternate sites of injection with this formulation and have been progressing other formulations. We are completing our analyses of these studies which will enable us to define the next steps in this program. The goal of our program is to develop LAI formulations that are effective, safe and well-tolerated with treatment durations of one month and longer.

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. We have completed a food intake study showing food had no significant impact on the pharmacokinetic (PK) profile. We have also completed Phase 1 safety studies demonstrating ITI-1284 is safe and generally well tolerated in normal healthy volunteers and normal healthy elderly volunteers. Other Phase 1 studies are ongoing or planned and include drug-drug interaction studies and mass balance studies. We also continue to progress our toxicology program for ITI-1284.

Phosphodiesterase type I inhibitor (PDE1) program: In our PDE 1 inhibitor program, for lenrispodun, we have recently completed or have ongoing Phase 1 trials including drug-drug interaction, bioavailability from scale up batches and food effect studies.

ITI-333 program: ITI-333 neuroimaging studies are ongoing. These studies are investigating brain occupancy for receptors related to substance use disorder and pain. Following these studies, we plan to initiate a multiple ascending dose study.

We presented at several medical conferences featuring CAPLYTA including the US Psych Congress and the European College of Neuropsychopharmacology (ECNP) Congress. In these conferences, we presented important data substantiating the favorable long-term safety profile of lumateperone in patients with bipolar depression, consistent with the long-term safety profile seen in our studies of lumateperone in patients with schizophrenia. We also presented analyses from our bipolar program including findings consistent with broad antidepressant effects, marked improvements in patients’ daily functioning, and further evidence of a favorable metabolic profile.

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.

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.

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Common stock, $0.0001 par value: 175,000,000 shares authorized at September 30, 2022 and December 31, 2021, 94,701,662 and 81,886,965 shares issued and outstanding at September 30, 2022 and December 31, 2021, respectively

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