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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

STALICLA and Firefly Neuroscience enterPartnership Agreement for the Development of Electroencephalogram (EEG) asa Biomarker for Subgroups of Patients with ASD The combination of STALICLA and FireflyNeurosciences’s machine learning platforms and know-how will further strengthen the development of precision medicine for these patients Geneva, Switzerland – 27March2023, STALICLA S.A. and Firefly Neuroscience today announced a partnership to further validate EEG-based biomarkers in biologically enriched subgroups of patients with Autism Spectrum Disorder (ASD). This follows the successful completion of STALICLA’s Phase 1b clinical trial for its lead asset STP1 where EEG measurement was shown to be a powerful predictor of efficacy. STALICLA and Firefly Neuroscience will leverage their technological platforms including the Databased Endophenotyping Patient Identification (DEPI) platform and the FDA-cleared Brain Network Analytics (BNA™) platform respectively to further advance EEG validation in two upcoming Phase 2 clinical trials, sponsored by STALICLA. Applying BNA™ to the DEPI-driven biologically enriched subgroups of patients with ASD is expected to establish and expand EEG as a biomarker in the field of ASD. EEG measurements will reinforce the DEPI stratification capacity and prediction of treatment response in patients with a behavioral diagnosis of ASD. STP1 is a tailored treatment candidate for ASD-Phenotype 1, the first DEPI-enriched subgroup of patients. STP1 positive target engagement was demonstrated by specific EEG signal modulation in brain areas of interest. Lynn Durham, STALICLA’s CEO & Founder, commented:“STALICLA is thrilled to partner with Firefly Neuroscience to advance an EEG-based treatment response marker in the NDD population. STALICLA will leverage its DEPI platform and Firefly Neuroscience’s technology to reinforce its leadership in precision medicine for neurodevelopmental disorders with rapid implementation of precision EEG in our upcoming two phase 2 programs in Autism Spectrum Disorder.” Jon Olsen, Firefly Neuroscience’s CEO, commented:“Firefly Neuroscience is excited to partner with STALICLA on the advancement of treatment for people with ASD. Using BNA™ to target sub-groups of patients for precision medicine treatment in the CNS space is a core focus for the company. The fact that BNA™ is FDA cleared and used by clinicians in the United States to support therapy decisions for people with mental disorders puts us in a very strong position to build a referral network in support of the commercialization of novel drugs and therapies for the treatment of NDD diseases.” STALICLA has developed and validated a machine learning platform, DEPI, allowing ASD subgroup identification and precision medicine treatment candidate selection. With multiple clinical proof of concepts, DEPI has allowed for the identification of two distinct subgroups of patients with ASD and their tailored treatments STP1 and STP2. Both STP1 and STP2 are planned to enter Phase 2 clinical trials in 2023. Firefly Neuroscience’s BNA™ platform is a patented technology that provides an objective, quantified assessment of cognition (brain function). It measures brain function and compares it to an FDA-cleared, normative, age-matched database using proprietary AI and advanced signal processing technology. Firefly Neuroscience’s AI platform (‘Fly-AI’) will help develop future biomarkers and companion diagnostics allowing for the expansion of existing pharma collaborations and partnerships to make the development of new CNS drugs more efficient. About STALICLA STALICLA is a precision molecular neuroscience clinical stage biotech company, advancing the first precision medicine platform (DEPI) for patients with neurodevelopmental disorders (NDDs), and neuropsychiatric disorders. STALICLA’s unique approach is addressing the poor construct validity of behaviourally defined disorders through its unique platform integrating molecular data with human genetic information to create testable clinical hypotheses in psychiatry and neuroscience. With multiple clinical proof of concepts, DEPI has allowed for the identification of two distinct subgroups of patients with Autism Spectrum Disorder (ASD) and their tailored treatments STP1 and STP2, both of which are planned to enter Phase 2 clinical trials in 2023. STP1 and STP2 hold a multi-billion market potential. The DEPI platform has been validated in a clinical setting showing high specificity, sensitivity and positive predictive value in prospectively designed trials recalling ‘high’ responder patients to previously failed drug candidates. STALICLA is currently preparing its next stage of growth to advance its pipelines and scale its platform. For further information, please visit: About Firefly Neuroscience Firefly Neuroscience leverages technical advances in computing and AI to deconstruct, analyze, and compare electroencephalograms (EEG), making them clinically useful for front-line clinicians to objectively measure, monitor, and manage brain function. Building on over a decade of research, the product has received FDA clearance and is commercially used in American clinics since mid-2022. With BNA™, clinicians and their patients can now make informed, objective therapy and disease management decisions, track changes over time and improve therapy compliance. It takes the guesswork and subjectivity out of managing mental illnesses and cognitive disorders- as one can only effectively manage what can accurately be measured. Firefly Neuroscience’s AI platform (‘Fly-AI’) has been built to develop future biomarkers and companion diagnostics (pharma) allowing for the expansion of existing pharma collaborations to bring new drugs to market. It has been used with leading companies such as Novartis, Takeda, and Purdue and is poised to revolutionize the required objective measurement for effective CNS drug development. For further information, please visit: Contacts STALICLA SA Lynn Durham, Founder & CEO Lynn.durham@stalicla.com Firefly Neuroscience Jon Olsen, CEO Jon.olsen@fireflyneuro.com Media inquiries Consilium Strategic Communications stalicla@consilium-comms.com