Intra-Cellular Therapies, Inc. (ITCI) announced positive top-line results from its late-stage study evaluating lumateperone 42 mg for the treatment of major depressive disorder (MDD). The stock climbed 23.3% on Apr 16 following the encouraging news. The stock hit a new 52-week high on Tuesday, driven by the significant pipeline development.The phase III study, called Study 501, evaluating lumateperone 42 mg given once daily as an adjunctive therapy to antidepressants for MDD, met the primary endpoint. A sta ...

Intra-Cellular Therapies (ITCI) shares rallied 23.3% in the last trading session to close at $79.84. This move can be attributable to notable volume with a higher number of shares being traded than in a typical session. This compares to the stock's 0.9% loss over the past four weeks.The sudden soaring of the share price was observed after the company announced meeting primary and key secondary endpoints in its phase III Study 501 evaluating lumateperone 42 mg as an adjunctive therapy to antidepressants for ...

NEW YORK, April 16, 2024 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (NASDAQ:ITCI) ("Intra-Cellular Therapies"), a biopharmaceutical company focused on the development and commercialization of therapeutics for central nervous system (CNS) disorders, today announced that it has commenced an underwritten public offering of $500 million of shares of its common stock. In connection with the offering, Intra-Cellular Therapies intends to grant the underwriters a 30-day option to purchase up to an additiona ...

Lumateperone 42 mg achieved statistically significant and clinically meaningful results in both the primary and the key secondary endpoints Lumateperone 42 mg met the primary endpoint of change from baseline at Week 6 on the Montgomery-Åsberg Depression Rating Scale (MADRS) total score versus placebo (4.9 point reduction v. placebo; p<0.0001; Cohen's d effect size (ES)= 0.61) Lumateperone 42 mg also met the key secondary endpoint of change from baseline at Week 6 on the Clinical Global Impression Scale for ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K ________________________ (Mark One) x ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 OR o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ________ to ________ Commission file number: 001-36274 Intra-Cellular Therapies, Inc. (Exact name of registrant as speci ...

Financial Performance - Full year 2023 total revenues reached $464.4 million, a significant increase from $250.3 million in 2022[1] - CAPLYTA net product sales for 2023 were $462.2 million, reflecting an 86% year-over-year growth, with fourth quarter sales of $131.5 million, up 50% from Q4 2022[4] - Total revenues for the year 2023 were $464.370 million, up 85.5% from $250.314 million in 2022[28] - Product sales for Q4 2023 reached $131.506 million, a 50.5% increase from $87.433 million in Q4 2022[28] - The net loss for Q4 2023 was $28.579 million, an improvement from a net loss of $44.026 million in Q4 2022[28] Expenses - SG&A expenses for 2023 were $409.9 million, up from $358.8 million in 2022, primarily due to increased commercialization and marketing costs[4] - R&D expenses for 2023 totaled $180.1 million, compared to $134.7 million in 2022, driven by higher costs associated with lumateperone and other projects[7] - Operating expenses for Q4 2023 totaled $166.196 million, compared to $135.281 million in Q4 2022, reflecting a 22.8% increase[28] - Research and development expenses for the year 2023 were $180.142 million, up 33.8% from $134.715 million in 2022[28] Cash Position - Cash and cash equivalents stood at $499.7 million as of December 31, 2023, down from $593.7 million a year earlier[7] - Cash and cash equivalents as of December 31, 2023, were $147.767 million, slightly down from $148.615 million at the end of 2022[30] - The company reported a total stockholders' equity of $591.424 million as of December 31, 2023, down from $656.070 million in 2022[30] Clinical Development and Pipeline - The company is advancing multiple clinical programs, including Phase 3 trials for lumateperone in major depressive disorder, with topline results expected in 2024[10] - The company is focused on expanding its pipeline, including new formulations and indications for lumateperone, with several studies expected to report results in 2024[11] - The company has plans for further commercialization of CAPLYTA, with ongoing clinical trials and regulatory submissions to the FDA[25] Market Access and Growth - CAPLYTA's market access now covers approximately 90% of commercially insured lives and over 99% of Medicare Part D and Medicaid lives[8] - CAPLYTA's acceptance among patients and physicians remains a key focus for future growth and market expansion[25] - The company projects CAPLYTA net product sales for 2024 to be between $645 million and $675 million[6] Risks - The company faces risks related to supply chain challenges and potential safety issues with CAPLYTA post-commercial launch[25]

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 _______________________ FORM 10-Q _______________________ (Mark One) x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 or o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from_________to_________ Commission File Number: 001-36274 _______________________ INTRA-CELL ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 _______________________ FORM 10-Q _______________________ (Mark One) x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 or o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from_________to_________ Commission File Number: 001-36274 _______________________ INTRA-CELLULAR ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 _______________________ FORM 10-Q _______________________ (Mark One) x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 or o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from_________to_________ Commission File Number: 001-36274 _______________________ INTRA-CELLULAR ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-36274 Intra-Cellular Therapies, Inc. (Exact name of registrant as specified in its charter) Delaware 36-4742850 (S ...