STALICLA

STALICLA is a clinical stage, precision molecular neuroscience biotech company with a mature pipeline for patients with Neurodevelopmental Disorders (NDDs) and Neuropsychiatric disorders. STALICLA’s unique approach addresses a principal weakness in the drug development process for NDD’s and neuropsychiatric disorders: behavior is a terrible biomarker. Clinical psychiatric and neurodevelopmental diagnoses encompass a broad diversity of underlying biology. This has contributed to drug develop... ment failure by diluting true responders in a population of patients with heterogeneous biology. STALICLA’s technology platform, DEPI, discovers biologically based endophenotypes within classical neuropsychiatric diagnostic groups. The AI/ML engine converges molecular data with human genetic information and non-behavioral clinical signs and symptoms, to define biologically related subgroups and create testable clinical hypotheses related to that biology. The DEPI platform has already completed several successful clinical validations, through the identification and biological validation of two distinct subgroups of patients with Autism Spectrum Disorder, ASD-Phenotype1 and ASD-Phenotype2, together with their predicted tailored treatment candidates (STP1 and STP2); as well as the blindly and retrospective calling “high” responder patients to previously failed drug candidates with high specificity, sensitivity, and positive predictive value. Further the completion of STP1 Phase 1b in 2022, STP1 will enter clinical Phase 2 in 2023; as well as STP2, a Phase 2 ready asset in licensed in Q4 ’22. Additionally, STALICLA will be advancing STP7, a recently in-licensed Phase 3 ready asset from Novartis, with strong potential for a neuropsychiatric indication, and whose clinical development will be fully financed by a non-dilutive funding to be announced in Feb. STALICLA is currently preparing its next stage of growth, to advance its pipelines and to scale its platform towards revenue generation.More