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May 2, 2024 – STALICLA SA, a late-stage biotechnology company specializing in precision medicine for brain disorders, announces the First Patient First Visit (FPFV) for the company's drug-drug interaction (DDI) study of STP7 (Mavoglurant), an mGluR5 negative allosteric modulator, licensed to STALICLA by Novartis. The DDI study is the last regulatory requirement in a comprehensive Phase 2 program and completion is expected to trigger initiation of a Phase 3 study in the U.S. in 2025. Lynn Durham, CEO and Founder of STALICLA said, “This DDI study unlocks the opportunity under our Cooperative Research and Development Agreement with the U.S. NIH National Institute of Drug Abuse (NIDA) to begin Phase 3 trials for STP7 in 2025 to address the high unmet medical need of cocaine abuse globally. Results from successfully completed Phase 2 studies for cocaine use disorder (CUD) showed highly convincing and unprecedented efficacy results including increase in abstinence from cocaine use and reduction in co-morbid dependencies such as alcohol abuse with STP7 (Mavoglurant). In addition, STALICLA is investigating alternative therapeutic indications for STP7 (Mavoglurant) to benefit patients with other CNS conditions.” STP7 (Mavoglurant) is the most clinically advanced negative allosteric modulator of the glutamate receptor 5 (mGluR5 NAM). As well as its role in addiction pathophysiology, mGluR5 has been implicated in mood disorders and neurodevelopmental disorders such as Fragile X and autism spectrum disorder. Comprehensive clinical studies by Novartis of STP7 (Mavoglurant) to date have included over 1800 adults for up to 2 years, demonstrating good safety and tolerability and significant reduction in cocaine use and positioning STP7 (Mavoglurant) as a strong candidate therapy for substance use and other CNS disorders. STALICLA SA is a Swiss clinical-stage biopharmaceutical company, pioneering precision treatment in neurodevelopmental and neuropsychiatric disorders. Its AI-driven precision neuro medicine platform has allowed to identify two precision small molecule drug candidates for autism spectrum disorder, STP1 and STP2, both planned to enter Phase 2 trials in 2024. Following the in-licensing of Mavoglurant from Novartis in 2023, STALICLA has also established an advanced mGluR5 NAM platform offering multi-faceted late-stage clinical development opportunities broadening STALICLA’s scope to address wider CNS disease unmet needs. For more information, please visit: www.stalicla.com. The content above comes from the network. if any infringement, please contact us to modify.

The ASD pipeline consists of 127 drugs spanning all stages of development, with only 7% of drugs present in Phase III and 11.8% in Phase II clinical development. Image Credit: Alex and Maria photo / Shutterstock. Switzerland-based Stalica has raised $17.5m in Series B financing to fund clinical trials for its neuropsychiatric and neurological disorders pipeline. The clinical programmes that the company plans to use the Series B proceeds include the fixed-dose combination drug STP1 and mavoglurant (STP7). Furthermore, the company will also strengthen the data package for STP2. Stalica’s clinical pipeline STP1 is a fixed dose combination of ibudilast, a phosphodiesterase (PDE) 4/3 inhibitor, and bumetanide, a sodium (Na)- potassium (K)- chloride (Cl) cotransporter (NKCC) 1 agonist. Stalica is developing the precision therapy as a treatment for autism spectrum disorder (ASD) in a specific sub-group of patients, phenotype 1 (Phen1). Phen1 patients have been identified by Stalica and validated using two independent clinical observational/bio-sampling studies (NCT05590715 and NCT04644003). The company is planning a Phase II trial for STP1 in patients with ASD, the preparation of which will be funded by the proceeds from the current financing round. Mavoglurant is a negative allosteric modulator of the glutamate receptor 5 (mGluR5). Stalica signed an in-licencing agreement with Novartis to develop the drug as a treatment for substance-use disorders and neurodevelopmental disorders (NDDs) in January 2023. As per the agreement, the company is entitled to receive up to $270m in upfront and milestone-based payments along with royalties on net sales. The company is planning a Phase III trial for mavoglurant in patients with cocaine use disorder in 2025. The trial will be funded by the US National Institute on Drug Abuse (NIDA), part of the US National Institutes of Health (NIH). It is expected to enrol up to 330 patients. STP2 is a stabilised synthetic form of sulforaphane. Stalica acquired the rights to the therapy from the UK-based Evgen Pharma in October 2022. Stalica is developing STP2 as a treatment for ASD in Phen2 sub-population. The company plans to start Phase II trial for the therapy in 2023. ASD landscape The total diagnosed prevalence of ASD was more than 9.81 million in 2023 and is expected to be approximately 9.65 million diagnosed prevalent cases of ASD in 2028, as per a 2023 Globaldata report . The ASD pipeline consists of 127 drugs spanning all stages of development, with only 7% of drugs present in Phase III and 11.8% in Phase II clinical development. GlobalData is the parent company of Pharmaceutical Technology . In November 2023, SciSparc started a clinical trial for SCI-210 to treat ASD symptoms in children. SCI-210 is a combination of cannabidiol (CBD) and palmitoylethanolamide. The trial is expected to enrol 60 patients aged five and 18 years. Apart from ASD treatment, strides have been made in developing diagnostics for the disorder. In September 2023, EarliTech positive data from two studies showing the efficacy and accuracy of its EarliPoint Evaluation device in diagnosing and assessing autism in children aged 30 months and older.

Geneva, Switzerland, January 16th, 2024 – Stalicla SA, a clinical-stage biopharmaceutical company advancing precision medicine pipelines for neuropsychiatric and neurological disorders, announces the successful completion of the first closing of its Series B financing round, securing $17.4 million. Led by SPRIM Global Investments Pte, Ltd, with key participation from core investors, this funding includes a $3.8 million credit facility. The proceeds will be utilized for: (i) preparation of Stalicla’s pioneering precision Autism Spectrum Disorder (ASD) Phase 2 trial – STP1; (ii) the establishment of its STP7 mGluR5 Negative Allosteric Modulator (mGluR5 NAM) platform, including the launch a Phase III study in Substance Use Disorders (SUDs) slated for 2025, fully supported by the NIH /National Institute on Drug Abuse; (iii) the ramp up of its ongoing biosampling/ patient identification trial STA-B-001 currently enrolling in sites in the USA, Spain and Australia. Alongside these key developments, Stalicla will further strengthen the package supporting its second precision ASD asset, STP2. Lynn Durham, CEO of Stalicla commented: “This financial backing underscores Stalicla's role as a trailblazer in the neuro precision space with first applications in precision psychiatry. Additionally, our STP7 mGluR5 NAM platform is offering multifaceted advanced clinical development opportunities in the wider neurology space in a timely period of recent clinical progress & increased transaction activity level in the neurology and neuropsychiatry space. There has never been a more promising time to advance transformative treatment options for millions of patients with brain diseases and Stalicla is determined to play a key role in this progress.” To support these advancements, Stalicla will strengthen its Management Team and Board of Directors, reinforcing the foundation for the exciting journey ahead. About STALICLA SASTALICLA is a precision molecular neuroscience clinical stage company, advancing through its DEPI precision neuro platform 2 precision autism assets: STP1 and STP2. Following the in-licensing of mavoglurant from Novartis in 2023, STALICLA has also established an advanced mGLuR5 NAM platform with multi-faceted late-stage clinical development opportunities.For further information, please visit: https://stalicla.com/ Contact:Stalicla SALynn Durham, Founder & CEOLynn.durham@stalicla.com Attachment Press Release 2024-01-SeriesB_final