In Q1 2018, STALICLA has closed a successful seed round of CHF 4M committed from high-profile biotech investors. STALICLA is currently engaged in a series A financing round to bring STP1 into clinical stage. Financing will also be invested in reinforcing DEPI technology.
Market potential and financials
- 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’s Breakthrough therapy designation program.
Drug combination and repurposing
Drug repurposing mitigates development risks through better defined safety profiles and reduced cost and time to market. Repurposed drugs can also benefit from very strong patent protection in the context of new indications, dosages or combinatory formulas.