Alto Neuroscience (ANRO) Corporate presentation summary

Mission and strategy

• Aims to redefine psychiatry by developing personalized, neurobiology-driven medicines for mental health conditions, focusing on precision medicine for the brain.

• Utilizes a biomarker-based approach to identify responsive patient populations and improve clinical outcomes in CNS disorders.

• Addresses unmet needs in mental health, targeting conditions like depression and schizophrenia, which are leading causes of disability.

• Strategy involves characterizing drug activity and patient selection using pharmacodynamic biomarkers to reduce trial-and-error treatments.

Pipeline overview and clinical programs

• Portfolio includes multiple clinical-stage programs: ALTO-207 (TRD), ALTO-300 (MDD), ALTO-100 (bipolar depression), ALTO-101 (CIAS), ALTO-203 (MDD), and ALTO-208 (Parkinson's).

• Over 900 patients dosed across studies, with mid- to late-stage data readouts expected in the next three years.

• ALTO-207 and ALTO-300 are advancing through Phase 2b and Phase 3 trials, with biomarker-guided patient selection.

• Expected cash runway through 2029, supported by a recent $275 million private placement.

ALTO-207 (TRD) highlights

• Combines a D3/D2 agonist (pramipexole) with a 5-HT3 antagonist (ondansetron) to enhance antidepressant effects and reduce dose-limiting side effects.

• Demonstrated robust antidepressant efficacy and improved tolerability, enabling higher dosing and faster titration.

• Phase 2a results showed significant symptom reduction and favorable safety profile; Phase 2b and Phase 3 trials are planned.

• Regulatory strategy leverages dopamine-related biomarkers for patient enrichment and streamlined development.