PDS-0101 is a subunit vaccine commercialized by PDS Biotechnology, with a leading Phase II program in Cervical Cancer. According to Globaldata, it is involved in 9 clinical trials, of which 3 were completed, 4 are ongoing, 1 is planned, and 1 was terminated. 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 $436 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. The company’s pipeline products include PDS01ADC + HDAC Inhibitor, PDS01ADC + Versamune HPV + ICI, PDS01ADC + Versamune MUC1 + ICI (Phase 1/2 anticipated 2024), Versamune HPV + HERE, PDS01ADC + Radiation therapy, Versamune HPV + Chemoradiotherapy – Immunicerv Trial, PDS01ADC + Docetaxel, PDS01ADC + Hepatic Artery Infusion Pump, Versamune HPV +/ KEYTRUDA, PDS01ADC, PDS0202 are for the treatment of metastatic colorecta, cervical cancer, castration resistant prostate cancer, liver cancers, colon and small bowel cancer, oropharyngeal cancer, kaposi sarcoma, flu vaccine. PDS Biotechnology is headquartered in Florham Park, New Jersey, the US.
The operating loss of the company was US$43.1 million in FY2023, compared to an operating loss of US$41.7 million in FY2022. The net loss of the company was US$42.9 million in FY2023, compared to a net loss of US$40.9 million in FY2022.
For a complete picture of PDS-0101’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.
