Newron Pharmaceuticals (NWRN) Investor presentation summary

Neurochemical rationale and unmet need

• Patients with treatment-resistant schizophrenia (TRS) show normal dopamine synthesis but elevated glutamate levels compared to healthy controls and responders to D2 antagonists.

• Current antipsychotics are only effective if dopamine activity is elevated and do not address cognitive or negative symptoms.

• Targeting glutamate modulation may address the underlying pathology in TRS.

Preclinical and mechanistic evidence

• Evenamide reverses hyperdopaminergic states, social deficits, and memory impairment in animal models, suggesting efficacy across positive, negative, and cognitive symptoms.

• Combination of evenamide with antipsychotics improved outcomes in animal models, rescuing ketamine-induced deficits.

Clinical trial design and patient population

• Phase 3, double-blind, placebo-controlled trial enrolled outpatients with chronic schizophrenia inadequately responding to stable doses of second-generation antipsychotics across 11 countries.

• Key inclusion: PANSS 70–85, CGI-S 4–6, moderate severity on core psychosis symptoms.

• Add-on treatment to standard of care, including clozapine.