Market potential and financials
Over the last five months STALICLA has closed a successful seed round supported by a group of high profile biotech investors. In 2018, STALICLA will engage in a series A financing round. This will allow STALICLA to bring STP1 to clinical phase. Clinical trials will establish a proof-of-principle for personalized ASD treatments using DEPI technology.
- In addition to the major toll ASD takes on the quality of life of patients and their families, it ranks among the highest costing diseases to healthcare and education systems. A 2015 study conducted by the UC-Davis Center for Healthcare Policy and Research pegged ASD’s economic costs for 2015 at $268 billion in the United States. These figures are similar to recent estimates for diabetes and attention deficit and hyperactivity disorder (ADHD) and exceed the costs of stroke and hypertension. Currently the only evidence-based treatment for ASD is behavioral intervention, which is associated with a yearly cost-per-patient ranging between $60,000 and $130,000.
- Initial target markets for STP1 are the US followed by the EU. Based on a conservative estimate of 1 in 110 for ASD prevalence (only including moderate to severe patients), the Phenotype 1 sub-population includes 15% of ASD patients or 1.2 million patients in the US and EU.
- First revenues are expected in 2025, after clinical trials for STP1 are completed and market authorization is granted. STP1’s target annual revenues after a ramp-up phase can be estimated to c. $2-3 billion/year.
Regulatory authorities have developed favorable frameworks and treatment development programs for unmet medical needs including the FDA programme for Breakthrough therapy designations and flexible Orphan Drug pricing negotiations. In addition, drug repurposing mitigates development risk which often results in reduced time and cost to market. There are also Intellectual Property advantages as repurposing makes it possible to obtain very strong patent protection for new uses of existing drugs.