DNL-310 is a fusion protein commercialized by Denali Therapeutics, with a leading Phase III program in Mucopolysaccharidosis II (MPS II) (Hunter Syndrome ). 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 DNL-310’s valuation in its risk-adjusted NPV model (rNPV). Buy the model here.

The revenue for DNL-310 is expected to reach an annual total of $44 mn by 2036 in the US 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.

DNL-310 Overview

DNL-310 is under development for the treatment of mucopolysaccharidosis II. The drug candidate is administered through intravenous route.The drug candidate consists of iduronate 2 sulfatase enzyme fused to Fc domain. It is developed based on enzyme transport vehicle (ETV) platform.

Denali Therapeutics Overview

Denali Therapeutics, is a clinical-stage bio-pharmaceutical company that focuses on the development of therapeutics for the treatment of neurodegenerative diseases. Its proprietary drug delivery platform technologies include antibody transport vehicle and enzyme transport vehicle designed to deliver large molecules across the blood-brain barrier (BBB). Its pipeline products are intended for the treatment of Alzheimer’s disease, dementia with Lewy bodies, Parkinson’s disease, multiple system atrophy, lysosomal storage disorder MPS II, neurodegeneration, amyotrophic lateral sclerosis and other indications. The company’s product pipeline include DNL201, DNL151, ATV:aSyn, for Parkinson’s disease, DNL747, ATV:Tau, ATV:TREM2, for Alzheimer’s disease; and CH1 and LF1, for neurodegeneration. It has development and commercialization rights to all of its programs, including the programs partnered with Takeda. The company has its operations in the UK and the US. Denali Therapeutics is headquartered in San Francisco, California, the US.

The company reported revenues of (US Dollars) US$48.7 million for the fiscal year ended December 2021 (FY2021), a decrease of 85.5% over FY2020. The operating loss of the company was US$295.8 million in FY2021, compared to an operating profit of US$62.7 million in FY2020. The net loss of the company was US$290.6 million in FY2021, compared to a net profit of US$71.1 million in FY2020. The company reported revenues of US$3.6 million for the third quarter ended September 2022, a decrease of 93.2% over the previous quarter.

For a complete picture of DNL-310’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.