FT-819 is a gene-modified cell therapy commercialized by Fate Therapeutics, with a leading Phase I program in Relapsed Chronic Lymphocytic Leukemia (CLL);Refractory Chronic Lymphocytic Leukemia (CLL);B-Cell Acute Lymphocytic Leukemia (B-Cell Acute Lymphoblastic Leukaemia). According to Globaldata, it is involved in 2 clinical trials, which are ongoing. GlobalData uses proprietary data and analytics to provide a complete picture of FT-819’s valuation in its risk-adjusted NPV model (rNPV). Buy the model here.
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The revenue for FT-819 is expected to reach an annual total of $77 mn by 2038 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.
FT-819 Overview
FT-819 is under development for the treatment of relapsed/refractory B-cell malignancies, including chronic lymphocytic leukemia (CLL), acute lymphoblastic leukemia (ALL), non-Hodgkin lymphoma (NHL), systemic lupus erythematosus, graft versus host disease and B cell lymphoma. The therapeutic candidate constitutes induced pluripotent stem cell (iPSC)-derived chimeric antigen receptor (CAR) 19 T cells (CD8 alpha beta plus cells). It is developed based on the iPSC technology-off-the-shelf using renewable engineered pluripotent cell lines. The drug candidate acts by targeting FCGR3 (CD16) and cells expressing B lymphocyte antigen CD19. It was also under development for the treatment of solid tumors. It is administered through intravenous route.
Fate Therapeutics Overview
Fate Therapeutics is a biopharmaceutical company that develops programmed cellular therapies for cancer and immune disorders. The company’s pipeline includes various off-the-shelf, iPSC-derived cellular immunotherapies for the treatment of several hematological malignancies and advanced solid tumors. Its pipeline products also include a donor-derived cell product candidate for the treatment of hematological malignancies. Fate Therapeutics uses its proprietary human-induced pluripotent stem cell (iPSC) platform for product development. The company also has research collaborations with companies, academic centers, and medical centers for the advancement of products and technologies. Fate Therapeutics is headquartered in San Diego, California, the US.
The company reported revenues of (US Dollars) US$63.5 million for the fiscal year ended December 2023 (FY2023), a decrease of 34% over FY2022. The operating loss of the company was US$190.5 million in FY2023, compared to an operating loss of US$308.4 million in FY2022. The net loss of the company was US$160.9 million in FY2023, compared to a net loss of US$281.7 million in FY2022.
The company reported revenues of US$6.8 million for the second quarter ended June 2024, compared to a revenue of US$1.9 million the previous quarter.
For a complete picture of FT-819’s valuation, buy the drug’s risk-adjusted NPV model (rNPV) here.
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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.
