Alto Neuroscience (ANRO) TD Cowen 46th Annual Health Care Conference summary

Strategic focus and pipeline overview

• Mission centers on transforming mental health care using precision psychiatry and biomarker-driven approaches.

• Pipeline includes late-stage programs for depression, treatment-resistant depression (TRD), bipolar depression, and cognition in schizophrenia.

• Two highlighted programs: ALTO-207 (depression/TRD) and ALTO-101 (cognition in schizophrenia).

• Additional phase II-B readouts expected this year for ALTO-300 (adjunctive depression) and ALTO-100 (bipolar depression).

• Cash runway extends into 2028, supporting multiple upcoming clinical milestones.

ALTO-207: Depression and treatment-resistant depression

• ALTO-207 combines pramipexole (dopamine agonist) and ondansetron (antiemetic) to improve efficacy and tolerability.

• Phase II-B trial to start in H1 this year, with phase III initiation planned for early next year; pivotal data expected in 2027.

• Prior studies (PAXD) showed strong efficacy (Cohen’s d ~0.9 at 12 weeks) and durable response up to 48 weeks in TRD.

• Main challenge is tolerability due to nausea/vomiting, addressed by co-formulation and modified release.

• IP protection extends into the mid-2040s, covering formulation, titration, and biomarker-defined populations.

ALTO-101: Cognition in schizophrenia

• Targets cognitive impairment in schizophrenia using a PDE4 inhibitor with a transdermal formulation for improved tolerability.

• Phase I data showed dose-related improvements in EEG biomarkers and cognition.

• Ongoing 83-patient crossover trial uses EEG as primary outcome; top-line data expected end of this quarter.

• Patient selection based on processing speed impairment enriches for EEG and cognitive deficits.

• Trial design aims to de-risk phase II-B by demonstrating circuit engagement and potential cognitive benefit.