Alto Neuroscience (ANRO) investor relations material

Conference overview

• The summit featured over 25 companies with a focus on CNS development, including depression, epilepsy, and BBB delivery, with sessions available on demand and in-person panels with key opinion leaders on June 15th.

Precision psychiatry platform and biomarker strategy

• Precision psychiatry aims to match patients to treatments using EEG and other biomarkers, moving from symptom-based to biology-based approaches.

• Machine learning is used to identify EEG signatures predicting treatment response and to define subgroups for targeted interventions.

• Each drug program is tailored to specific biological or cognitive markers, optimizing patient selection and trial design.

ALTO-207 program highlights

• ALTO-207 is a fixed-dose combination of pramipexole and ondansetron, targeting treatment-resistant depression (TRD) with a hypodopaminergic phenotype identified by EEG.

• The co-formulation allows higher, faster dosing by mitigating nausea, with efficacy supported by the PAX-D study showing a large effect size and durable response.

• Phase II-B trial began in early Q2, with readout expected in the second half of 2027 and potential phase III start by early 2027, pending regulatory alignment.

• Study design mirrors successful prior trials, using adjunctive treatment in TRD patients and a starter pack titration schedule for ease of use.

• Safety benchmarks are set against antipsychotics, with focus on minimizing dropouts due to adverse events and managing long-term risks like somnolence and impulse control disorders.