Intra-Cellular Therapies, Inc. (Nasdaq: ITCI) reported strong financial and clinical progress for the fourth quarter and full year 2024, driven by significant growth in CAPLYTA sales and continued advancements in its drug development pipeline.

For the full year, CAPLYTA net product sales reached $680.5 million, reflecting a 47% year-over-year increase. In the fourth quarter alone, sales grew 51% to $199.2 million compared to the same period in 2023. The company ended 2024 with cash, cash equivalents, investment securities, and restricted cash totaling $1.0 billion, up from $499.7 million at the end of 2023.

Operating expenses also increased, with selling, general, and administrative (SG&A) expenses rising to $504.5 million, primarily due to expanded commercialization efforts. Research and development (R&D) expenses grew to $236.1 million, reflecting higher costs associated with ongoing clinical programs, including lumateperone and other pipeline candidates.

On the regulatory front, the FDA accepted for review a supplemental New Drug Application (sNDA) for lumateperone as an adjunctive treatment for major depressive disorder (MDD). The submission is supported by positive results from Phase 3 clinical trials.

The company continues to expand its clinical pipeline, launching 10 late-stage trials in 2024, including six Phase 3 lumateperone studies and four ITI-1284 studies. Key ongoing programs include:
- **Lumateperone:** Pediatric Phase 3 trials for irritability in autism spectrum disorder, studies in bipolar mania, and ongoing schizophrenia and bipolar disorder safety trials.
- **ITI-1284:** Phase 2 trials for generalized anxiety disorder and psychosis or agitation in Alzheimer’s disease.
- **PDE1 inhibitor program:** Phase 2 study of lenrispodun (ITI-214) in Parkinson’s disease and a Phase 1 trial of ITI-1020 for oncology.
- **ITI-1500 neuroplastogen program:** ITI-1549 is advancing through IND-enabling studies.

Looking ahead, the company is expanding its sales force in anticipation of CAPLYTA's potential approval for adjunctive MDD treatment. With a robust cash position and ongoing clinical advancements, Intra-Cellular Therapies is well-positioned for continued growth in 2025.