NEW YORK, Nov. 09, 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 third quarter ended September 30, 2020, and provided a corporate update.

“Our Company is in a strong position. CAPLYTA is approved for the treatment of schizophrenia in adults and I am pleased with the prescription growth of CAPLYTA as we continue to provide this important medicine to patients. In addition, we have a broad development plan for lumateperone in other major neuropsychiatric conditions. We are soon submitting an sNDA for lumateperone for a second major indication, bipolar depression and initiating late stage studies in adjunctive MDD and in major depressive episodes with mixed features in patients with either bipolar disorder or MDD,” said Dr. Sharon Mates, Chairman and CEO of Intra-Cellular Therapies. “Our robust pipeline including our LAI formulation of lumateperone, ITI-214 and ITI-333 continue to advance and we are well capitalized to fund our commercial activities and development programs.”

CORPORATE UPDATE

COMMERCIAL HIGHLIGHTS

• Third quarter CAPLYTA results reflect strong commercial execution delivering continued robust week-over-week and quarter-over-quarter prescription growth; third quarter total prescriptions increased by approximately 280% versus the previous quarter. Our commercial organization continues to adapt to the dynamic COVID-19 environment and effectively engage with our prescribing audience through a mix of personal and non-personal activities. Importantly, healthcare practitioners’ feedback on patient experience with CAPLYTA continues to be very positive.
• CAPLYTA’s market access continues to be 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 support eligible patients’ access pathway for CAPLYTA.

CLINICAL HIGHLIGHTS

Lumateperone - Bipolar Depression Program:

• In September 2020, we reported positive topline results from Study 402, a 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. Lumateperone 42 mg met the primary endpoint for improvement in depression as measured by change from baseline versus placebo on the MADRS total score (p=0.0206). Lumateperone 42 mg also met the key secondary endpoint, the CGI-BP-S Depression Score (p=0.0082). Lumateperone demonstrated a favorable safety profile and was generally well-tolerated in the trial. Rates of akathisia, restlessness, extrapyramidal symptoms, and changes in weight were similar to placebo, consistent with the safety profile demonstrated in our prior studies in schizophrenia and bipolar depression.
• Study 402, in conjunction with our previously reported positive Phase 3 monotherapy study, Study 404, forms the basis for our supplemental new drug application (sNDA) for the treatment of bipolar depression in patients with Bipolar I or II disorder as monotherapy and adjunctive therapy. Our sNDA preparations remain on track and we expect to submit our application to the U.S. Food and Drug Administration (FDA) early in the first quarter of 2021 and anticipate an FDA target action date for the application in the second half of 2021. There are over 11 million adult Americans living with Bipolar disorder. Lumateperone has the potential to be the only approved treatment for bipolar depression in patients with either Bipolar I or Bipolar II disorder as an adjunctive treatment to mood stabilizers or as monotherapy.

Lumateperone - Development in Major Depressive Disorder (MDD) and other depressive disorders and advancing a Long-Acting Injectable (LAI) formulation

• We have amended our ongoing monotherapy bipolar depression study, Study 403, to focus on studying lumateperone in two patient populations: patients with MDD as well as patients with bipolar depression who present clinically with mixed features. This global study evaluates lumateperone 42 mg. The primary endpoint is change from baseline on the Montgomery–Åsberg Depression Rating Scale (MADRS) total score at week 6 versus placebo.

  In a post-hoc analysis of Study 404, in a subgroup of patients with bipolar depression with mixed features, lumateperone 42 mg had a statistically significant improvement from baseline on the MADRS total score versus placebo (p=0.003). These findings will be presented at future medical meetings.

  Approximately one third of patients with either MDD or bipolar depression can exhibit manic symptoms that are below the clinical threshold for mania or hypomania. These patients respond poorly to antidepressants, have greater symptom severity, have a higher risk of suicide attempts, and experience severe illness with more co-morbidities. The fifth edition of the Diagnostic and Statistical Manual of Mental Disorders or DSM-5 incorporates a mixed features specifier as a way to better characterize these patients.

• We have commenced our Phase 3 clinical program evaluating lumateperone 42 mg as an adjunctive therapy to antidepressants for the treatment of MDD. Clinical conduct in two Phase 3 trials is anticipated to begin in 2021.

Lumateperone Long Acting Injectable (LAI) formulation:

• We recently completed a successful Type C meeting with the FDA. We plan to initiate clinical testing of our lumateperone long-acting injectable program later this year. An ascending single dose safety and pharmacokinetic (PK) study will be conducted followed by a multiple ascending dose safety and PK study administered subcutaneously.

Other Programs

• ITI-333: Based on a pre-IND meeting held with the FDA, we expect to initiate a single ascending dose safety and tolerability study evaluating ITI-333, our novel compound for the treatment of substance use disorders, in late 2020 or early 2021. We have received a grant from the National Institute on Drug Abuse as part of the NIH HEAL (Helping to End Addiction Long-term) initiative to support the early clinical development of ITI-333 for the treatment of opioid use disorder.

Selected Third Quarter 2020 Financial Results

The Company recorded net product sales of CAPLYTA for the third quarter of 2020 of approximately $7.4 million. No net product sales were reported for the comparable period of 2019.

The Company reported a net loss of $55.2 million, or $0.79 per share (basic and diluted), for the third quarter of 2020 compared to a net loss of $34.9 million, or $0.63 per share (basic and diluted), for the third quarter of 2019.

Research and development (R&D) expenses for the third quarter of 2020 were $10.3 million, compared to $21.3 million for the third quarter of 2019. The $11.0 million decrease is due primarily to a decrease of approximately $6.2 million of lumateperone clinical and non-clinical costs, a decrease of approximately $2.9 million in research manufacturing costs and overhead, a decrease of $2.7 million for other projects, and is offset by an increase of $0.7 million for stock based compensation.

Selling, general and administrative (SG&A) expenses were $52.5 million for the third quarter of 2020, compared to $15.0 million for the same period in 2019. Selling expenses were $38.3 million for the quarter ended September 30, 2020 as compared to pre-commercialization expenses of $6.4 million in the same period in 2019. This selling expense increase is primarily due to increases in sales related labor expenses of $15.4 million and commercialization and marketing expenses of $15.2 million. General and administrative expenses were $14.2 million in the quarter ended September 30, 2020 as compared to $8.6 million for the same period in 2019. This increase is due to increases in information technology expenses of $2.4 million, professional fees of $1.4 million, stock compensation expense of $1.4 million, labor and related expense of $0.4 million, and the remainder in other administrative expenses.

Cash, cash equivalents, restricted cash and investment securities totaled $723.3 million at September 30, 2020, compared to $224.0 million at December 31, 2019. In September 2020, the Company completed a public offering resulting in net proceeds to the Company of approximately $358 million, after deducting underwriting discounts and commissions and offering expenses, from the sale of 12.7 million shares of its common stock.

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.

CAPLYTA (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.

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.