PDS-0101 is a subunit vaccine commercialized by PDS Biotechnology, with a leading Phase II program in Vaginal Cancer;Vulvar Cancer. According to Globaldata, it is involved in 9 clinical trials, of which 3 were completed, 5 are ongoing, and 1 is planned. GlobalData uses proprietary data and analytics to provide a complete picture of PDS-0101’s valuation in its risk-adjusted NPV model (rNPV). Buy the model here.

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The revenue for PDS-0101 is expected to reach an annual total of $148 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.

PDS-0101 Overview

PDS-0101 is under development for the treatment of HPV-induced cancers which includes cervical intraepithelial neoplasia (cervical dysplasia). It is administered through subcutaneous route. It targets HPV-16. The drug candidate contains Versamune nanoparticles and multiple short HPV strain-16 viral proteins. The drug candidate is developed by Versamune nanotechnology platform. Versamune nanotechnology facilitates efficient processing of the disease related protein and its presentation to the T-cells of the immune system.

It is also under development for the treatment of human papillomavirus z (hpv) infection related head and neck cancer, HPV16 and PD-L1 positive recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). anal cancer, hpv associated vulvar cancer, vaginal cancer, penile cancer, cervical cancer, oropharyngeal cancer, squamous cell rectal cancers, lung cancer, esophageal cancer and oropharyngeal cancer.

PDS Biotechnology Overview

PDS Biotechnology is a biopharmaceutical company that develops vaccines and immunotherapies for cancer and infectious disease. It is investigating PDS0101 for the treatment of head and neck, HPV-positive anal, cervical, penile, vaginal, vulvar cancers and pre-metastatic HPV-associated oropharyngeal cancer (OPSCC); PDS-0201 to prevent tuberculosis; PDS0202 targeting influenza; and PDS0203 against COVID-19. The company is also evaluating PDS0102 for TARP-associated AML (acute myeloid leukemia), prostate and breast cancers; PDS0103 against MUC1-associated breast, colon, lung, ovarian and other cancers; and PDS0104 to treat melanoma. It utilizes Versamune and Infectimune, T-cell immune activating platform technologies. PDS Biotechnology is headquartered in Florham Park, New Jersey, the US.

The operating loss of the company was US$41.7 million in FY2022, compared to an operating loss of US$21.4 million in FY2021. The net loss of the company was US$40.9 million in FY2022, compared to a net loss of US$16.9 million in FY2021.

For a complete picture of PDS-0101’s valuation, buy the drug’s risk-adjusted NPV model (rNPV) here.

This content was updated on 7 February 2024

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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.