Study of ALTO-101 in Patients With Schizophrenia

Inclusion Criteria:

• Schizophrenia diagnosis for at least one year

• Cognitive impairment

• Stable doses of 1-2 antipsychotic medication(s) for at least 8 weeks at Visit 2

• Positive and Negative Syndrome Scale (PANSS) score: items P1, P3-P6 ≤ 5 and item P2and P7 ≤ 4 during screening

• Have a body mass index (BMI) ≥ 18.0 and ≤ 37.0 kg/m2 (inclusive)

• Willing to comply with all study assessments and procedures

Exclusion Criteria:

• Evidence of unstable medical condition

• Acute psychiatric decompensation or severity of symptoms requiring psychiatrichospitalization in past 6 months

• Diagnosis of schizoaffective or bipolar affective disorder, dementia, orintellectual disability

• Current episode of major depressive disorder (MDD)

• Use of mood stabilizer, clozapine, and/or daily benzodiazepine

• Current moderate or severe substance use disorder