AV-101 is a small molecule commercialized by VistaGen Therapeutics, with a leading Phase I program in Drug-Induced Dyskinesia. According to Globaldata, it is involved in 8 clinical trials, of which 5 were completed, 1 is ongoing, and 2 are planned. GlobalData uses proprietary data and analytics to provide a complete picture of AV-101’s valuation in its risk-adjusted NPV model (rNPV). Buy the model here.
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The revenue for AV-101 is expected to reach an annual total of $89 mn by 2038 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.
AV-101 Overview
AV-101 is under development for the treatment of dyskinesia associated with levodopa therapy for Parkinson’s disease. The drug candidate is administered through oral route in the form of capsule. It acts by targeting NMDA receptors and AMPA receptors. AV-101 is a pro-drug that is converted in the brain into an active metabolite, 7-chlorokynurenic acid (7-Cl-KYNA). It was also under development for the treatment of resistant depression, neuropathic pain, Huntington's disease, major depressive disorder and epilepsy.
VistaGen Therapeutics Overview
VistaGen Therapeutics (VistaGen) is a clinical-stage biopharmaceutical company that develops new-generation medicines for depression and neuropsychiatric disorders. The company’s pipeline product, AV-101, currently under Phase 2 clinical development, is an oral N-methyl-D-aspartate receptor glycine B intended to treat major depressive disorder. Its other pipeline products comprise PH94B treats social anxiety disorder and PH10 nasal spray treats major depressive disorder. The company offers its products in the form of sprays and oral administration. It partners with other healthcare industries for research and assessment of drug effects on cardiac risk. VistaGen is headquartered in South San Francisco, California, the US.
The company reported revenues of (US Dollars) US$1.1 million for the fiscal year ended March 2024 (FY2024), compared to a revenue of US$0.2 million in FY2023. The operating loss of the company was US$33 million in FY2024, compared to an operating loss of US$59.3 million in FY2023. The net loss of the company was US$29.4 million in FY2024, compared to a net loss of US$59.3 million in FY2023.
The company reported revenues of US$0.1 million for the first quarter ended June 2024, a decrease of 57.4% over the previous quarter.
For a complete picture of AV-101’s valuation, buy the drug’s 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.
