Gedatolisib is a small molecule commercialized by Celcuity, with a leading Phase III program in Human Epidermal Growth Factor Receptor 2 Negative Breast Cancer (HER2- Breast Cancer). According to Globaldata, it is involved in 22 clinical trials, of which 8 were completed, 4 are ongoing, 3 are planned, and 7 were terminated. GlobalData uses proprietary data and analytics to provide a complete picture of Gedatolisib’s valuation in its risk-adjusted NPV model (rNPV). Buy the model here.
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The revenue for Gedatolisib is expected to reach an annual total of $155 mn by 2034 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.
Gedatolisib Overview
Gedatolisib (PF-05212384, PKI-587) is under development for ER+/HER2-negative metastatic breast cancer, HER-2 positive breast cancer and triple-negative breast cancer, head and neck cancer squamous cell carcinoma, small-cell lung cancer, pancreatic cancer, metastatic hormone refractory (castration resistant, androgen-independent) prostate cancer, solid tumor endometrial cancer, ovarian cancer, cervical cancer and unspecified. It is administered as intravenous infusion. The drug candidate acts by targeting dual PI3K/mTOR. It was also under development for endometrial cancer as second and third line therapy, metastatic colorectal cancer, glioblastoma, renal cancer and pancreatic ductal adenocarcinoma.
It was under development for the treatment of relapsed refractory acute myeloid leukemia and myelodysplastic syndrome, non-small cell lung cancer, squamous small cell lung carcinoma, endometrial cancer, ovarian cancer, cervical cancer, metastatic breast cancer, metastaic ovarian cancer, esophagal-gastric cancer, head and neck cancer squamous cell carcinoma and hormone refractory (castration resistant, androgen-independent) prostate cancer, transitional cell cancer (urothelial cell cancer), oropharyngeal cancer, ovarian cancer and pancreatic cancer.
Celcuity Overview
Celcuity is a clinical-stage biotechnology company specializing in developing targeted therapies for the treatment of multiple solid tumor indications. The company’s lead therapeutic candidate is gedatolisib, a potent, pan-PI3K and mTOR inhibitor for the treatment of breast cancer, prostate cancer and gynecological cancer. Celcuity is also developing VIKTORIA-1, VIKTORIA-2 and CELC-G-201 therapeutics. The company utilizes the CELsignia platform, to identify abnormal oncogenic signaling pathways in cancer patients. It partners with pharmaceutical companies to evaluate targeted therapies’ efficacy in cancer patients. Celcuity is headquartered in Minneapolis, Minnesota, the US.
The operating loss of the company was US$66.2 million in FY2023, compared to an operating loss of US$39.4 million in FY2022. The net loss of the company was US$63.8 million in FY2023, compared to a net loss of US$40.4 million in FY2022.
For a complete picture of Gedatolisib’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.
