Study of Efficacy of PEAR-004 in Schizophrenia

Key Inclusion Criteria:

- Signed informed consent must be obtained prior to participation in the study.

- Healthy male and female subjects 18 to 65 years of age, inclusive, and in good health
as determined by medical history, physical examination, and vital signs at screening

- SCID-based DSM-5 diagnosis of schizophrenia and a total PANSS score > 60

- Proficient in English at 5th grade reading level or higher, in the judgement of the
investigator

- Capable of using a mobile device (compatible with PEAR-004) and using common
applications, in the judgement of the investigator

Key Exclusion Criteria:

- Major change in primary antipsychotic medication in the prior 4 weeks before screening
(e.g., switching to a new agent or a dose adjustment within two weeks of
randomization)

- Planning to move out of the geographic area within 3 months

- Unable to use English to participate in the consent process, the interventions or
assessments

- Inability to comply with study procedures, due to severe medical conditions or
otherwise

- Meet DSM-5 diagnosis for a current episode of major depression, mania, or hypomania in
the past month

- Meet DSM-5 diagnosis for a current moderate or severe alcohol or cannabis use disorder
in the past 2 months

- Meet DSM-5 diagnosis for a current substance use disorder (other than alcohol or
cannabis) in the past 2 months

- Considered high risk for suicidal behavior based on ISST-Plus score at screening, or
in the judgement of the investigator

- Previously participated in a clinical study involving PEAR-004

Other criteria may apply.