Intra-Cellular Therapies (ITCI) Canaccord Genuity 44th Annual Growth Conference & Private Company Showcase 2024 summary

Company overview and product success

• Achieved initial product approval in 2019 for schizophrenia, followed by approval for bipolar depression, with strong launches despite the pandemic.

• Recently completed robust pivotal studies for major depressive disorder (MDD) as adjunctive treatment, with an sNDA filing expected in the second half of the year.

• Product demonstrates high compliance and persistency due to favorable safety and tolerability, leading to use across multiple lines of therapy, especially as first or second-line in bipolar depression.

• Prescriber base exceeds 43,000, growing by 3,000-4,000 new prescribers each quarter, with increasing prescription depth per physician.

• Sales force expansion underway, with 150 representatives by quarter-end and further expansion planned ahead of MDD approval.

Pipeline and research initiatives

• Pipeline includes pediatric programs, long-acting injectable formulations, phosphodiesterase 1 inhibitors for Parkinson's and cancer, and early-stage neuroplastogen (non-hallucinogenic psychedelic) candidates.

• Long-acting injectable formulations are being developed for non-compliant patients, with new one- and two-month formulations entering testing.

• Pediatric studies in bipolar disorder and autism spectrum disorder are robust, with trial listings forthcoming.

• Deuterated lumateperone (1284) is being studied for Alzheimer's psychosis, agitation, and generalized anxiety disorder, with potential PK advantages and ongoing phase 2/3 studies.

• Neuroplastogen 1549 is a novel, non-hallucinogenic molecule showing rapid-acting antidepressant potential and favorable safety in animal models.

Clinical and regulatory strategy

• Two positive phase III trials and a positive mixed features trial in MDD support the upcoming sNDA; a backup trial (505) is under consideration but not required for filing.

• Prospective trials in mixed features depression leveraged DSM-5 criteria, addressing a significant unmet need.

• No major changes expected in gross-to-net strategy with MDD label expansion, as payers manage at the brand level.

• BEHAVE-AD scale chosen for 1284 Alzheimer's agitation trial after discussions with FDA, as it measures both severity and frequency of events.