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Sep 30, 2020
Intra-Cellular Q3 2020 Earnings Report
Intra-Cellular Therapies reported strong Caplyta commercial performance and positive topline results from a Phase 3 study evaluating lumateperone as an adjunctive treatment for bipolar depression.
Key Takeaways
Intra-Cellular Therapies reported net product sales of CAPLYTA for the third quarter of 2020 of approximately $7.4 million. The company is preparing sNDA for the treatment of bipolar depression for submission to the FDA and expanding lumateperone development in Major Depressive Disorder (MDD).
Reported positive topline results from Study ‘402, a Phase 3 Study evaluating lumateperone as an adjunctive treatment to lithium or valproate in patients with bipolar depression.
Preparing sNDA for the treatment of bipolar depression for submission to the FDA.
Strong CAPLYTA commercial performance with week-over-week and quarter-over-quarter prescription growth despite COVID-19 disruptions.
Expanding lumateperone development in Major Depressive Disorder (MDD) and other depressive disorders and advancing a Long-Acting Injectable (LAI) formulation
Intra-Cellular
Intra-Cellular
Forward Guidance
The company plans to submit an sNDA to the FDA for lumateperone for the treatment of bipolar depression, initiate clinical studies in major depressive disorder, initiate human testing of our lumateperone long-acting injectable program, and initiate early stage clinical studies for ITI-333.
Positive Outlook
- 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.
- Commencing two Phase 3 clinical studies evaluating lumateperone as an adjunctive therapy to antidepressants for the treatment of MDD.
- Initiating clinical studies of our lumateperone LAI subcutaneous formulation.
- 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.
- Continue to advance our robust pipeline including our LAI formulation of lumateperone, ITI-214 and ITI-333
Challenges Ahead
- There are no guarantees that CAPLYTA will be commercially successful
- We may encounter issues, delays or other challenges in commercializing CAPLYTA
- The COVID-19 pandemic may negatively impact our commercial plans and sales for CAPLYTA
- We may encounter unexpected safety or tolerability issues with CAPLYTA following commercial launch for the treatment of schizophrenia or in ongoing or future trials and other development activities
- Our proposals with respect to the regulatory path for our product candidates may not be acceptable to the FDA