Alto Neuroscience (ANRO) Jefferies 2024 Global Healthcare Conference summary

Strategic vision and differentiation

• Focus on precision psychiatry using objective brain biomarkers to match patients with effective treatments, inspired by advances in oncology and immunology.

• Developed scalable, meaningful assessments like cognitive tests and EEGs to identify patient subgroups for targeted drug development.

• Portfolio includes four clinical programs, each targeting different psychiatric populations and disorders.

• Approach aims for larger treatment effects by prospectively validating biomarkers before large-scale trials.

• Emphasizes commercial scalability and generalizability across psychiatric conditions.

Clinical pipeline and timelines

• ALTO-100 phase IIb in depression with poor cognition to read out in the second half of 2024.

• ALTO-300 phase IIb in depression with a specific EEG signature and ALTO-203 phase II proof-of-concept in high anhedonia depression to read out in the first half of 2025.

• ALTO-101 phase II proof-of-concept in cognitive impairment with schizophrenia expected in 2025.

• All trials use prospectively validated biomarkers to enrich for likely responders.

• Internal clinical operations team manages trials to ensure consistency and quality.

Regulatory and industry context

• Approach aligns with FDA's enrichment guidelines, similar to recent successful programs in the field.

• FDA engagement is ongoing, with a stepwise process to validate biomarkers and guide phase III design.

• Few competitors use objective biomarkers in CNS; field is moving toward precision approaches.