ITI-1284 is a small molecule commercialized by Intra-Cellular Therapies, with a leading Phase II program in Generalized Anxiety Disorder (GAD). According to Globaldata, it is involved in 7 clinical trials, of which 2 were completed, 3 are ongoing, and 2 are planned. GlobalData uses proprietary data and analytics to provide a complete picture of ITI-1284s valuation in its risk-adjusted NPV model (rNPV). Buy the model here.
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The revenue for ITI-1284 is expected to reach an annual total of $38 mn by 2036 globally based off GlobalDatas Expiry Model. The drugs 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 drugs 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) is a biopharmaceutical company that discovers, develops, and commercializes small molecule drugs that address underserved medical needs primarily in neuropsychiatric and neurological disorders. The company pipeline includes lumateperone for major depressive disorder and bipolar depression; TI-1284-ODT-SL for the treatment of agitation and psychosis in patients with Alzheimers; ITI-1500 series ITI-1549. ICTI’s other pipeline includes PDE inhibitor for Parkinsons and cancer immunotherapy and ITI-333 for opioid use disorder, pain and mood disorders. It also utilizes CNSProfile, a technology platform that monitors the phosphoprotein changes elicited by major psychotropic drug classes and subclasses and generates a unique molecular signature for drug compounds. ICTI is headquartered in New York, the US.
The company reported revenues of (US Dollars) US$464.4 million for the fiscal year ended December 2023 (FY2023), an increase of 85.5% over FY2022. The operating loss of the company was US$159.4 million in FY2023, compared to an operating loss of US$263.6 million in FY2022. The net loss of the company was US$139.7 million in FY2023, compared to a net loss of US$256.3 million in FY2022.
The company reported revenues of US$144.9 million for the first quarter ended March 2024, an increase of 9.7% over the previous quarter.
For a complete picture of ITI-1284s valuation, buy the drugs risk-adjusted NPV model (rNPV) here.
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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.
