Minerva Neurosciences, Inc.

We are a clinical-stage biopharmaceutical company focused on developing and commercializing proprietary product candidates for central nervous system (CNS) diseases. Our primary product candidate is roluperidone, which is being developed to treat negative symptoms in patients with schizophrenia. In August 2022, we submitted a New Drug Application (NDA) for roluperidone to the FDA for this indication. On February 26, 2024, the FDA issued a Complete Response Letter (CRL) regarding our NDA. Following the CRL, we have engaged with the FDA to confirm the design of an additional Phase 3 confirmatory clinical trial, referred to as the C19 trial, to address the deficiencies in the CRL and support an NDA resubmission. Similar to the completed Phase 2b (C03) and Phase 3 (C07) trials, the C19 trial will enroll patients diagnosed with schizophrenia who have stable impairing negative symptoms and stable positive symptoms for six months prior to trial entry. We agreed with the FDA to aim for 25-30% of patients from the United States, subject to competitive recruitment. The FDA confirmed that roluperidone can be studied as a monotherapy, with patients receiving a double-blinded single daily 64 mg dose of roluperidone or placebo. For a monotherapy indication, the FDA advised assessing relapses observationally for at least 52 weeks in patients treated with roluperidone, placebo, or antipsychotics. The FDA also stated it would consider an NDA resubmission with a double-blind, placebo- or active-controlled trial of at least 52 weeks, with the primary efficacy endpoint at week 12. Subject to ongoing FDA feedback, the C19 trial is currently expected to begin, with the first patient screened, in the second quarter of 2026.