ITI-1284 is a small molecule commercialized by Intra-Cellular Therapies, with a leading Phase I program in Psychosis. According to Globaldata, it is involved in 6 clinical trials, of which 2 were completed, 1 is ongoing, and 3 are planned. GlobalData uses proprietary data and analytics to provide a complete picture of ITI-1284’s valuation in its risk-adjusted NPV model (rNPV). Buy the model here.

The revenue for ITI-1284 is expected to reach an annual total of $32 mn by 2035 globally based off GlobalData’s Expiry Model. The drug’s revenue forecasts along with estimated costs are used to measure the value of an investment opportunity in that drug, otherwise known as net present value (NPV). Applying the drug’s phase transition success rate to remaining R&D costs and likelihood of approval (LoA) to sales related costs provides a risk-adjusted NPV model (rNPV). The rNPV model is a more conservative valuation measure that accounts for the risk of a drug in clinical development failing to progress.

ITI-1284 Overview

Deuterated lumateperone (ITI- 1284) is under development for the treatment of behavioural disturbances in dementia, dementia-related psychosis, agitation in patients with probable Alzheimer’s disease (AD), generalized anxiety disorders and certain depressive disorders in the elderly. It is a deuterated form of lumateperone, a new molecular entity formulated as an orally disintegrating tablet for sublingual administration. It targets 5-hydroxytryptamine receptor 2A (5 HT2A), D2 receptor and the serotonin transporter. It is being developed based on Zydis ODT (orally disintegrating tablet) fast-dissolving formulation.

Intra-Cellular Therapies Overview

Intra-Cellular Therapies (ICTI) carries out the discovery, clinical development and commercialization of innovative, small molecule drugs that address underserved medical needs primarily in neuropsychiatric and neurological disorders by targeting intracellular signaling mechanisms within the central nervous system. The company develops drugs for the treatment of heart failure, immune system regulation, neurodegenerative diseases, cancers and other non-CNS disorders. Its pipeline products include lumateperone (ITI-007) which is used for the treatment of schizophrenia, behavioral disturbances associated with dementia and Alzheimer’s disease, bipolar disorder and behavioral disturbances such as dementia and Alzheimer’s disease. ICTI is headquartered in New York City, New York, the US.

The company reported revenues of (US Dollars) US$83.8 million for the fiscal year ended December 2021 (FY2021), compared to a revenue of US$22.8 million in FY2020. The operating loss of the company was US$285.7 million in FY2021, compared to an operating loss of US$231.2 million in FY2020. The net loss of the company was US$284.1 million in FY2021, compared to a net loss of US$227 million in FY2020. The company reported revenues of US$71.9 million for the third quarter ended September 2022, an increase of 29.3% over the previous quarter.

For a complete picture of ITI-1284’s valuation, buy the drug’s risk-adjusted NPV model (rNPV) here.

GlobalData

GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

To create this model, GlobalData takes into account factors including patent law, known and projected regulatory approval processes, cash flows, drug margins and company expenses. Combining these data points with GlobalData’s world class analysis creates high value models that companies can use to help in evaluation processes for each drug or company.

The rNPV method integrates the probability of a drug reaching a clinical stage into the cash flow at that time, which provides a more accurate valuation, as it considers the probability that the drug never makes it through the clinical pathway to commercialization. GlobalData’s rNPV model uses proprietary likelihood of approval (LoA) and phase transition success rate (PTSR) data for the indication in the highest development stage, which can be found on GlobalData’s Pharmaceutical Intelligence Center.