Saniona (SANION) investor relations material

Pipeline overview and program updates

• SAN2668 is the lead internal development program, targeting severe pediatric epilepsies, especially developmental and epileptic encephalopathies (DEEs), and is positioned as a potential first-in-class therapy.

• The program aims to address high unmet medical needs in neurology by improving seizure control and reducing side effects associated with current treatments.

• SAN2668 is designed to maintain benzodiazepine-like efficacy while minimizing chronic use limitations.

• Internal pipeline also includes SAN2219 for epilepsy and SAN2465 for major depressive disorder.

Clinical trial data and development milestones

• Preclinical data show robust seizure control across multiple models, including spike-wave discharges and focal seizures.

• The clinical development strategy includes phase I studies with translational biomarkers, PET imaging, and a photosensitivity study, aiming for first-in-human dosing early next year.

• An open-label pediatric study will precede a randomized, placebo-controlled phase II trial measuring both seizure and non-seizure endpoints.

• Planned Phase 1 clinical development strategy for SAN2668 will be discussed at the upcoming R&D Day.

R&D strategy and innovation priorities

• The approach leverages validated biomarkers for rapid de-risking and objective evidence of activity.

• Quantitative EEG and PET imaging will guide dose selection and differentiation from existing therapies.

• Ion channel discovery platform underpins the pipeline and is validated through multiple research collaborations.

• Series of webinars planned to highlight differentiated CNS pipeline assets.