A Study to Evaluate Safety and Tolerability of CVL-231 (Emraclidine) in Adult Participants With Schizophrenia

Inclusion Criteria:

1. Completed 6 weeks of post-randomization treatment in Trial CVL-231-2001 (NCT05227690) or CVL-231-2002 (NCT05227703) and who, in the opinion of theinvestigator, could potentially benefit from treatment with emraclidine forschizophrenia.

2. Primary diagnosis of schizophrenia per Diagnostic and Statistical Manual of MentalDisorders, Fifth Edition (DSM-5), as confirmed by the Mini InternationalNeuropsychiatric Interview (MINI) for Psychotic Disorders.

3. Participants who have been stable on antipsychotic medication for at least one 3-month in the year prior to screening.

4. Outpatient status at the time of signing the informed consent form informed consentform (ICF).

5. Willing to discontinue all prohibited medications to meet protocol-required washoutsprior to and during the trial period.

6. Ability, in the investigator's opinion, to understand the nature of the trial,participate in trial visits, and comply with protocol requirements.

Exclusion Criteria:

1. Current DSM-5 diagnosis other than schizophrenia (note: anxiety symptoms secondaryto schizophrenia are allowed.

• Acute depressive symptoms within 30 days prior to signing the ICF that requiretreatment with an antidepressant are exclusory.

• Acute manic symptoms within 30 days prior to signing the ICF that requiretreatment with a mood stabilizer are exclusory.

2. Any of the following:

• Schizophrenia is considered resistant/refractory to antipsychotic treatment byhistory (failure to respond to 2 or more courses of adequate pharmacologicaltreatment defined as an adequate dose per label and a treatment duration of atleast 4 weeks).

• History of response to clozapine treatment only or failure to respond toclozapine treatment.

3. Current or past history of significant cardiovascular, pulmonary, gastrointestinal,renal, hepatic, metabolic, genitourinary, endocrine (including diabetes mellitus),malignancy (except for basal cell carcinoma of the skin and cervical carcinoma insitu, at the discretion of the investigator), hematological, immunological,neurological, or psychiatric disease that, in the opinion of the investigator ormedical monitor, could compromise either participant safety or the results of thetrial.

4. Active central nervous system infection, demyelinating disease, degenerativeneurological disease, brain tumor, prior hospitalization for severe head trauma,seizures (excluding febrile seizures in childhood), or any central nervous systemdisease deemed to be progressive during the trial that may confound theinterpretation of the trial results

5. Diagnosis of moderate to severe substance or alcohol use disorder (excludingnicotine or caffeine) as per DSM-5 criteria within 12 months prior to signing theICF.

6. Risk for suicidal behavior as assessed by the C-SSRS and investigator's clinicalassessment.

7. Any condition that could possibly affect drug absorption, including, but not limitedto bowel resections, bariatric weight loss surgery, gastric banding, and gastrectomy

8. Use of prohibited medications prior to randomization within the required wash-outperiod or likely to require prohibited concomitant therapy during the trial.

9. Clinically significant abnormal findings on the physical examination, medicalhistory review, ECG, or clinical laboratory results at screening.

10. Positive pregnancy test result prior to receiving investigational medicinal product (IMP).

Note: female participants who are pregnant, breastfeeding, or planning to become pregnant during IMP treatment or within 7 days after the last dose of the IMP are also excluded.