Since May 2017, STALICLA has raised CHF 24.6 M (USD 27.4 M) In three distinct financing rounds from high-profile biotech investors in Switzerland, Europe and US:
STALICLA will be closing its series B in Q2 2022. Proceeds will support the advancement of STP1 and STP2 in phase 2 clinical trials as well as the identification of new candidates.
Autism spectrum disorder (ASD) is a highly prevalent condition, which affects about 7-10M patients in the US and the EU. The Center for Disease Control estimated prevalence in the US at 1/56 (CDC, 2020) and the European Commission evaluates prevalence in 7-9-year-old children at 1/89 in the EU (2018).
ASD is diagnosed through behavior and perceived as homogenous, when it is in fact heterogeneous and can be segmented by genetic background, phenotype and clinical presentation. In essence, there is no autism, but different types of autisms and 80% of patients are idiopathic (unknown causes).
Hence, behavioral diagnostics of autism spectrum disorder do not offer insights into its biology and are the culprit of repeated failure of previous clinical trials. In a study conducted by the UC-Davis Center for Healthcare Policy and Research, the annual cost of ASD in United States in 2015 was estimated at USD 268 billion, projected to rise to USD 461 billion by 2025. This is comparable to costs for diabetes and exceeds costs for stroke and hypertension.
Autism spectrum disorder remains a high unmet medical need. Educational and behavioral care can cost up to USD 60K-120K per year..
There are currently no approved treatments for the core symptoms of autism spectrum disorder. Only two atypical neuroleptics have been approved for autism spectrum disorder, none of which addresses the core symptoms and bear a high-level of adverse effects.
STALICLA brings a unique systems-based characterization of clinically and biologically meaningful patient subgroups, thereby setting the stage for personalized drug discovery in autism spectrum disorder.
STALICLA's DEPI drug discovery platform stands as a multi-stream value creation model. As part of its on-going development, DEPI offers a broad potential and can be extended to other complex neurodevelopment disorders.
Initial target markets for STP1 and STP2 are the US followed by the EU. Based on a preliminary reasonable assessment (an incidence of ASD-Phen1 of 20-25%, and ASD-Phen2 of 20% of the idiopathic ASD population; a prescription rate similar to the FDA-approved anti-psychotic drugs for irritability in ASD (30%); and a conservative drug pricing range for STP1 and STP2 comprised between USD 3,000 to USD 9,000 per patient, per year, the initial addressable market is estimated above $ 1.0B / year for each STP1 and STP2 personalized treatment.