Alto Neuroscience (ANRO) investor relations material

Mission and strategic focus

• Aims to redefine psychiatry by developing personalized, neurobiology-driven medicines for faster patient recovery.

• Focuses on precision medicine for brain disorders, leveraging biomarkers to segment patients and improve outcomes.

• Portfolio targets major unmet needs in psychiatry, including depression, bipolar disorder, and cognitive impairment.

Pipeline and clinical programs

• Late-stage pipeline includes ALTO-207 for treatment-resistant depression (TRD), ALTO-300 for major depressive disorder (MDD), and ALTO-100 for bipolar depression.

• ALTO-207 combines pramipexole and ondansetron to enhance efficacy and tolerability, with Phase 2b and Phase 3 trials ongoing or planned.

• ALTO-300 (agomelatine) is being developed as an adjunctive MDD treatment, guided by an EEG biomarker, with Phase 2b topline data expected in 1H 2027.

• ALTO-100 targets cognitive deficits in bipolar depression, using a cognitive biomarker for patient selection, with Phase 2b data expected mid-2027.

• Additional candidates include ALTO-101 (PDE4 inhibitor for cognition) and ALTO-203 (H3 inverse agonist for neuropsychiatric disorders).

Clinical results and differentiation

• ALTO-207 enables higher pramipexole doses with improved tolerability, achieving greater antidepressant effects than current TRD treatments.

• Phase 2a data for ALTO-207 showed significant reductions in depressive symptoms and illness severity versus placebo.

• ALTO-300 demonstrates favorable efficacy and tolerability compared to antipsychotics and esketamine, with low risk of liver function test elevation at 25mg.

• Biomarker-guided approaches for ALTO-300 and ALTO-100 aim to enrich for likely responders and improve trial outcomes.